Register entry

Haleon US Holdings LLC

Data as of · How to read this entry

Registered sites
8
Active NDC listings
405
Live patents
10
Countries
4
Base
United States
Authorisation

Registered operations

Analytical testing8Labelling6Finished drug manufacture7Packaging7
Sites

Registered establishments

8
EstablishmentAddressRegistered forFEI / DUNS
Pf Soins De Sante SRIRegistrant: Haleon US Holdings LLC1025 Marcel Laurin Boulevard, Saint-Laurent, Quebec H4R 1J6, Canada (CAN)Analytical testing, Labelling, Finished drug manufacture, Packaging3002806439203812479
Haleon CH SARLRegistrant: Haleon US Holdings LLCRoute de l'Etraz 2, Nyon, 1260, Switzerland (CHE)Analytical testing, Labelling, Finished drug manufacture, Packaging3027331049480004233
Haleon Ireland Dungarvan LimitedRegistrant: Haleon US Holdings LLCKnockbrack, Dungarvan, Co. Waterford X35RY76, Ireland (IRL)Analytical testing, Finished drug manufacture, Packaging3003721894986062659
Haleon US Holdings LLC3169 Rt 145, East Durham, New York (NY) 12423, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging1314819046877908
PF Consumer Healthcare B.V. (Puerto Rico Operations) LLCRegistrant: Haleon US Holdings LLCState Rd No. 3 (Km. 143.8), Guayama, Puerto Rico (PR) 00784, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging3007343300118346012
Haleon US Inc.Registrant: Haleon US Holdings LLC10401 HWY 6, Lincoln, Nebraska (NE) 68517, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging1911445129836151
Haleon US Holdings LLC1211 Sherwood Ave, Richmond, Virginia (VA) 23220, United States (USA)Analytical testing1119620828831730
Haleon US Holdings LLC320 South Broadway, St. Louis, Missouri (MO) 63102, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging1940882099673899
Catalogue

Drug listings by form and route

405

405 active NDC listings: 384 human otc drug, 20 drug for further processing, 1 bulk ingredient. By marketing category: OTC MONOGRAPH DRUG 292, NDA 82, DRUG FOR FURTHER PROCESSING 20, ANDA 10, EXPORT ONLY 1.

Dosage formNDCs
paste65
tablet, chewable48
tablet, coated32
kit27
tablet, film coated24
tablet19
lozenge17
liquid16
capsule, liquid filled15
powder, for solution15
solution14
stick14
gum, chewing13
syrup11
patch, extended release9
RouteNDCs
oral278
dental33
topical32
nasal7
rectal4
transdermal3
Labeller name on the listingNDCs
haleon us holdings llc405
Exclusivity

Patents and exclusivities

10
PatentProductCoversExpiry
7863287ADVIL ALLERGY SINUSchlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochlorideproductFeb 2027
8323683NICORETTEnicotine polacrilexproductApr 2028
8347879FLONASE SENSIMIST ALLERGY RELIEFfluticasone furoateproductJul 2028
8147461FLONASE SENSIMIST ALLERGY RELIEFfluticasone furoateproductOct 2028
8940772NICORETTEnicotine polacrilexproductApr 2029
8501164NICORETTEnicotine polacrilexproductJun 2029
11918693ADVIL DUAL ACTION WITH ACETAMINOPHENacetaminophen; ibuprofenproductJul 2041
Catalogue

Marketed products

405

Showing 150 of 405.

BrandGeneric nameForm / routeNDC
4 Way Fast ActingPhenylephrine hydrochloridespray, nasal0067-2086OTC MONOGRAPH DRUG
ABREVAdocosanolcream, topical0135-0200NDA
ABREVAdocosanolcream, topical0135-0300ANDA
ABREVA Rapid Pain Reliefglycerin, lidocainegel, topical0135-0400OTC MONOGRAPH DRUG
ADVILibuprofentablet, coated, oral0573-0150NDA
ADVILibuprofentablet, coated, oral0573-0151NDA
ADVILibuprofentablet, coated, oral0573-0154NDA
ADVILibuprofentablet, coated, oral0573-0160NDA
ADVILibuprofentablet, coated, oral0573-0161NDA
ADVILibuprofentablet, coated, oral0573-0165NDA
ADVILibuprofentablet, coated, oral0573-0166NDA
ADVILibuprofentablet, coated, oral0573-1711NDA
ADVIL ALLERGY SINUSchlorpheniramine maleate, ibuprofen, pseudoephedrine HCltablet, coated, oral0573-0188NDA
ADVIL COLD AND SINUSibuprofen and pseudoephedrine hydrochloridetablet, coated, oral0573-0180NDA
ADVIL COLD AND SINUSibuprofen, pseudoephedrine hydrochloridecapsule, liquid filled, oral0573-0184NDA
ADVIL COLD AND SINUSibuprofen and pseudoephedrine hydrochloridetablet, coated, oral0573-2160NDA
ADVIL DUAL ACTION WITH ACETAMINOPHENIbuprofen, Acetaminophentablet, film coated, oral0573-0147NDA
ADVIL DUAL ACTION WITH ACETAMINOPHEN Back PainIbuprofen, Acetaminophentablet, film coated, oral0573-0145NDA
ADVIL MIGRAINEibuprofencapsule, liquid filled, oral0573-0168NDA
ADVIL PMdiphenhydramine HCl, ibuprofencapsule, liquid filled, oral0573-0148NDA
ADVIL PMdiphenhydramine citrate and ibuprofentablet, coated, oral0573-0164NDA
ADVIL PMdiphenhydramine HCl, ibuprofencapsule, liquid filled, oral0573-0167NDA
ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochloridetablet, coated, oral0573-0199NDA
ALLIorlistatcapsule, oral0135-0461NDA
AQUAFRESH CAVITY PROTECTIONsodium fluoridepaste, dental0135-0590OTC MONOGRAPH DRUG
AQUAFRESH EXTRA FRESH PLUS WHITENINGsodium fluoridepaste, dental0135-0591OTC MONOGRAPH DRUG
AQUAFRESH EXTREME CLEAN WHITENING ACTIONsodium fluoridepaste, dental0135-0234OTC MONOGRAPH DRUG
AQUAFRESH SENSITIVE MAXIMUM STRENGTHpotassium nitrate and sodium fluoridepaste, dental0135-0605OTC MONOGRAPH DRUG
-Acetaminophen, aspirin, caffeinetablet, film coated0067-4202DRUG FOR FURTHER PROCESSING
Advilibuprofen sodiumtablet, coated, oral0573-0133NDA
Advilibuprofen sodiumtablet, coated, oral0573-0134NDA
Advilibuprofencapsule, liquid filled, oral0573-0149NDA
Advilibuprofencapsule, liquid filled, oral0573-0169NDA
Advilibuprofencapsule, liquid filled, oral0573-1769NDA
Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloridetablet, coated, oral0573-0196NDA
Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloridetablet, coated, oral0573-2161NDA
Advil Menstrual Painibuprofen sodiumtablet, coated, oral0573-0230NDA
Advil Multi-Symptom Cold and Fluchlorpheniramine maleate, ibuprofen, phenylephrine HCltablet, coated, oral0573-0190NDA
Advil Targeted Reliefcamphor, capsaicin, menthol, methyl salicylatecream, topical0573-6555OTC MONOGRAPH DRUG
Aquafresh Extreme Clean Pure Breath Actionsodium fluoridepaste, dental0135-0604OTC MONOGRAPH DRUG
BIOTENE Fresh Mint Originalsodium fluoridepaste, oral0135-0557OTC MONOGRAPH DRUG
BIOTENE Gentle Mintsodium fluoridepaste, oral0135-0558OTC MONOGRAPH DRUG
CHAPSTICK CLASSIC MEDICATEDcamphor, menthol, petrolatumstick, topical0573-2031OTC MONOGRAPH DRUG
CHILDRENS ADVILibuprofensuspension, oral0573-0170NDA
CHILDRENS ADVILibuprofensuspension, oral0573-0171NDA
CHILDRENS ADVILibuprofensuspension, oral0573-0174NDA
CHILDRENS ADVILibuprofensuspension, oral0573-0207NDA
CHILDRENS ADVILibuprofensuspension, oral0573-0232NDA
CHILDRENS ADVILibuprofensuspension, oral0573-0290NDA
CHILDRENS ADVILibuprofensuspension, oral0573-1174NDA
CHILDRENS FLONASE ALLERGY RELIEFfluticasone propionatespray, metered, nasal0135-0582NDA
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTINGchlorpheniramine maleate, dextrometrorphan HBrliquid, oral0031-8693OTC MONOGRAPH DRUG
CITRUCELmethylcellulosepowder, for solution, oral0135-0089OTC MONOGRAPH DRUG
CITRUCELmethylcellulosepowder, for solution, oral0135-0090OTC MONOGRAPH DRUG
CITRUCELmethylcellulosetablet, oral0135-0199OTC MONOGRAPH DRUG
ChapStick Classic Cherrywhite petrolatumstick, topical0573-0705OTC MONOGRAPH DRUG
ChapStick Classic Originalwhite petrolatumstick, topical0573-0701OTC MONOGRAPH DRUG
ChapStick Classic Spearmintwhite petrolatumstick, topical0573-0711OTC MONOGRAPH DRUG
ChapStick Classic SpearmintPETROLATUMstick, topical0573-1912OTC MONOGRAPH DRUG
ChapStick Classic Strawberrywhite petrolatumstick, topical0573-0715OTC MONOGRAPH DRUG
ChapStick Supreme Classic Cherrywhite petrolatumstick, topical0573-1921OTC MONOGRAPH DRUG
Chapstickavobenzone, octinoxate, and white petrolatumkit0573-2027OTC MONOGRAPH DRUG
Chapstick 12 Days of Christmaswhite petrolatumkit0135-2029OTC MONOGRAPH DRUG
Chapstick 12 Days of Christmaswhite petrolatumkit0573-0804OTC MONOGRAPH DRUG
Chapstick Active 2in1 Variety Packzinc oxidekit0573-0803OTC MONOGRAPH DRUG
Chapstick Holiday Classics Kitwhite petrolatumkit0573-0805OTC MONOGRAPH DRUG
Chapstick Moisturizer Cool Mintavobenzone, octinoxate, and white petrolatumstick, topical0573-0768OTC MONOGRAPH DRUG
Chapstick Moisturizer Cool Mintavobenzone, homosalate, octisalate, octocrylene, white petrolatumstick, topical0573-1957OTC MONOGRAPH DRUG
Chapstick Moisturizer Originalavobenzone, octinoxate, and white petrolatumstick, topical0573-0725OTC MONOGRAPH DRUG
Chapstick Moisturizer Originalavobenzone, homosalate, octisalate, octocrylene, white petrolatumstick, topical0573-1958OTC MONOGRAPH DRUG
Chapstick Moisturizer Variety Packavobenzone, homosalate, octisalate, octocrylene, white petrolatumkit0573-1959OTC MONOGRAPH DRUG
Chapstick Total Hydration Moisture Tint Peachy Keenzinc oxidestick, topical0573-0871OTC MONOGRAPH DRUG
Chapstick Total Hydration Moisture Tint Pretty in Pinkzinc oxidestick, topical0573-0873OTC MONOGRAPH DRUG
Chapstick Total Hydration Moisture Tint Very Berryzinc oxidestick, topical0573-0872OTC MONOGRAPH DRUG
Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexsuspension, extended release, oral0031-8725ANDA
Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexsuspension, extended release, oral0031-8726ANDA
Childrens Robitussin Cough Long-Actingdextromethorphan hydrobromideliquid, oral0031-8694OTC MONOGRAPH DRUG
Childrens Robitussin Cough and Chest Congestion DMdextromethorphan hydrobromide and guaifenesinliquid, oral0031-8702OTC MONOGRAPH DRUG
Childrens Robitussin Cough and Chest Congestion DMdextromethorphan hydrobromide, guaifenesinliquid, oral0031-8715OTC MONOGRAPH DRUG
Childrens Robitussin Cough and Cold CFdextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochlorideliquid, oral0031-8716OTC MONOGRAPH DRUG
Childrens Robitussin Elderberry Cough and Chest Congestion DMdextromethorphan HBr, guaifenesinsolution, oral0031-2098OTC MONOGRAPH DRUG
Childrens Robitussin Honey Cough and Chest Congestion DMdextromethorphan HBr, guaifenesinsolution, oral0031-8760OTC MONOGRAPH DRUG
Childrens Robitussin Honey Nighttime Cough DMdextromethorphan hbr, doxylamine succinatesolution, oral0031-8762OTC MONOGRAPH DRUG
Childrens Robitussin Nighttime Cough Long-Acting DMchlorpheniramine maleate, dextromethorphan hydrobromidesolution, oral0031-8692OTC MONOGRAPH DRUG
-Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloridesyrup0031-8729EXPORT ONLY
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVESENNOSIDESpill, oral0067-8142OTC MONOGRAPH DRUG
EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVESENNOSIDEStablet, chewable, oral0067-8140OTC MONOGRAPH DRUG
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVESENNOSIDEStablet, oral0067-8141OTC MONOGRAPH DRUG
EXCEDRIN MIGRAINEAcetaminophen, Aspirin (NSAID) and Caffeinetablet, film coated, oral0067-2039NDA
EXCEDRIN MIGRAINEAcetaminophen, Aspirin (NSAID) and Caffeinetablet, film coated, oral0067-8201NDA
Excedrin Extra Strength GeltabsAcetaminophen, Asprin, Caffeinetablet, coated, oral0067-2021OTC MONOGRAPH DRUG
Excedrin Extra Strength HeadacheAcetaminophen, Aspirin (NSAID), Caffeinetablet, film coated, oral0067-2002OTC MONOGRAPH DRUG
Excedrin Extra Strength HeadacheAcetaminophen, Aspirin (NSAID), Caffeinetablet, film coated, oral0067-2003OTC MONOGRAPH DRUG
Excedrin Extra Strength Pain RelieverAcetaminophen, Aspirin (NSAID), and Caffeinetablet, film coated, oral0067-2000OTC MONOGRAPH DRUG
Excedrin Extra Strength Pain RelieverAcetaminophen, Aspirin (NSAID), and Caffeinetablet, film coated, oral0067-2001OTC MONOGRAPH DRUG
Excedrin Extra Strength Pain RelieverAcetaminophen, Aspirin (NSAID), and Caffeinetablet, film coated, oral0067-8202OTC MONOGRAPH DRUG
Excedrin Extra Strength Pain RelieverAcetaminophen, Aspirin (NSAID), and Caffeinetablet, film coated, oral0067-8203OTC MONOGRAPH DRUG
Excedrin Extra Strength and Excedrin Tension HeadacheAcetaminophen, Aspirin (NSAID), and Caffeinekit0067-8151OTC MONOGRAPH DRUG
Excedrin MigraineAcetaminophen, Aspirin, and Caffeinetablet, film coated, oral0067-2040NDA
Excedrin Migraine GeltabsAcetaminophen, Asprin, Caffeinetablet, coated, oral0067-2035NDA
Excedrin Migraine ReliefAcetaminophen, Aspirin (NSAID), Caffeinetablet, film coated, oral0067-2042NDA
Excedrin PM Triple Action CapletsAcetaminophen, Aspirin (NSAID) and Diphenhydramine Citratetablet, coated, oral0067-2056OTC MONOGRAPH DRUG
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain RelieverAcetaminophen, Aspirin (NSAID), Caffeine, and Diphenhydramine Citratekit0067-8148OTC MONOGRAPH DRUG
Excedrin PM Triple Action Caplets and Excedrin Tension HeadacheAcetaminophen, Aspirin (NSAID), Caffeine, and Diphenhydramine Citratekit0067-8147OTC MONOGRAPH DRUG
Excedrin Rapid Reliefacetaminophentablet, oral0067-2200OTC MONOGRAPH DRUG
Excedrin Tension HeadacheAcetaminophen, Caffeinetablet, film coated, oral0067-8139OTC MONOGRAPH DRUG
FLONASE ALLERGY RELIEFfluticasone propionatespray, metered, nasal0135-0576NDA
FLONASE Headache and Allergy Reliefacetaminophen, chlorpheniramine maleate, phenylephrine hcltablet, oral0135-0578OTC MONOGRAPH DRUG
FLONASE SENSIMIST ALLERGY RELIEFfluticasone furoatespray, metered, nasal0135-0615NDA
FLONASE SENSIMIST ALLERGY RELIEFfluticasone furoatespray, metered, nasal0135-0616NDA
GAVISCONaluminum hydroxide and magnesium carbonateliquid, oral0135-0094OTC MONOGRAPH DRUG
GAVISCONaluminum hydroxide and magnesium carbonateliquid, oral0135-0095OTC MONOGRAPH DRUG
GAVISCONaluminum hydroxide and magnesium carbonateliquid, oral0135-0574OTC MONOGRAPH DRUG
Gas-X Extra StrengthSimethiconetablet, chewable, oral0067-0117OTC MONOGRAPH DRUG
Gas-X Extra StrengthSimethiconetablet, chewable, oral0067-0129OTC MONOGRAPH DRUG
Gas-X Extra Strength SoftgelsSimethiconecapsule, liquid filled, oral0067-6275OTC MONOGRAPH DRUG
Gas-X Maximum Strength SoftgelsSimethiconecapsule, liquid filled, oral0067-6283OTC MONOGRAPH DRUG
Gas-X Total Relief Maximum StrengthCalcium carbonate, Simethiconetablet, chewable, oral0067-0118OTC MONOGRAPH DRUG
Gas-X Total Relief Maximum StrengthCalcium carbonate, Simethiconetablet, chewable, oral0067-0119OTC MONOGRAPH DRUG
Gas-X Ultimate Strength SoftgelsSimethiconecapsule, liquid filled, oral0067-8075OTC MONOGRAPH DRUG
Gas-X Ultra Strength AntiGas SoftgelsSimethiconecapsule, liquid filled, oral0067-6274OTC MONOGRAPH DRUG
Gaviscon Extra Strengthaluminum hydroxide and magnesium carbonatetablet, chewable, oral0135-0098OTC MONOGRAPH DRUG
Gaviscon Extra Strengthaluminum hydroxide and magnesium carbonatetablet, chewable, oral0135-0430OTC MONOGRAPH DRUG
INFANTS ADVILibuprofensuspension/ drops, oral0573-0191NDA
-Ibuprofentablet, coated10158-066DRUG FOR FURTHER PROCESSING
JUNIOR STRENGTH ADVILibuprofentablet, coated, oral0573-0175NDA
JUNIOR STRENGTH ADVILibuprofentablet, chewable, oral0573-0179NDA
NATEAN Clean and Whitensodium fluoridepaste, oral0135-1200OTC MONOGRAPH DRUG
NATEAN Clean plus Sensitivity Reliefpotassium nitrate, sodium fluoridepaste, oral0135-1250OTC MONOGRAPH DRUG
NICODERM CQnicotinepatch, extended release, transdermal0135-0194NDA
NICODERM CQnicotinepatch, extended release, transdermal0135-0195NDA
NICODERM CQnicotinepatch, extended release, transdermal0135-0196NDA
NICORETTEnicotine polacrilexlozenge, oral0135-0508NDA
NICORETTEnicotine polacrilexlozenge, oral0135-0510NDA
NICORETTEnicotine polacrilexlozenge, oral0135-0511NDA
NICORETTEnicotine polacrilexlozenge, oral0135-0625NDA
NICORETTEnicotine polacrilexlozenge, oral0135-0626NDA
NICORETTEnicotine polacrilexlozenge, oral0135-0635ANDA
NICORETTEnicotine polacrilexlozenge, oral0135-0636ANDA
NICORETTEnicotine polacrilexlozenge, oral0135-1500NDA
NICORETTEnicotine polacrilexlozenge, oral0135-2800NDA
Nexium 24HResomeprazole magnesiumcapsule, delayed release, oral0573-2450NDA
Nexium 24HResomeprazole magnesiumtablet, oral0573-2451NDA
Nexium 24HR ClearMinisesomeprazole magnesiumcapsule, delayed release, oral0573-2452NDA
Nicorette Cherry Peppermintnicotine polacrilexlozenge, oral0135-8070NDA
Nicorette Cherry Peppermintnicotine polacrilexlozenge, oral0135-8071NDA
Nicorette Cinnamon Surgenicotine polacrilexgum, chewing, oral0135-0466NDA
Nicorette Cinnamon Surgenicotine polacrilexgum, chewing, oral0135-0467NDA
Nicorette Fruit Chillnicotine polacrilexgum, chewing, oral0135-0241NDA
Nicorette Fruit Chillnicotine polacrilexgum, chewing, oral0135-0242NDA
Neighbours

Registered in the same town

12
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Enquiry

Common questions

Is Haleon US Holdings LLC FDA approved?
Haleon US Holdings LLC holds 8 FDA-registered establishments across 4 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Haleon US Holdings LLC's drugs manufactured?
At registered sites in Canada, Switzerland, Ireland, the United States. The FDA register lists Saint-Laurent; Nyon; Dungarvan; East Durham, NY; Guayama, PR; Lincoln, NE, and 2 more. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Haleon US Holdings LLC make?
405 products are listed under Haleon US Holdings LLC in the openFDA NDC Directory, most often as paste; tablet, chewable; tablet, coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.