Haleon US Holdings LLC

Registered sites: 8
Drug products: 402
Live patents: 10
Countries: 4
Base: United States

Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

Analytical testingLabellingFinished drug manufacturePackaging

Sites

Facilities

Site	Location	Operations	FEI
Pf Soins De Sante SRI	Saint-LaurentCanada	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002806439
Haleon CH SARL	NyonSwitzerland	Analytical testing, Labelling, Finished drug manufacture, Packaging	3027331049
Haleon Ireland Dungarvan Limited	DungarvanIreland	Analytical testing, Finished drug manufacture, Packaging	3003721894
Haleon US Holdings LLC	East Durham, NYUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging	1314819
PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC	Guayama, PRUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging	3007343300
Haleon US Inc.	Lincoln, NEUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging	1911445
Haleon US Holdings LLC	Richmond, VAUnited States	Analytical testing	1119620
Haleon US Holdings LLC	St. Louis, MOUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging	1940882

Exclusivity

Patents

Unexpired Orange Book patents where this company is the application holder.

Product	Active ingredient	Expiry
ADVIL ALLERGY SINUS	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	Feb 2027
ADVIL DUAL ACTION WITH ACETAMINOPHEN	ACETAMINOPHEN; IBUPROFEN	Jul 2041
FLONASE SENSIMIST ALLERGY RELIEF	FLUTICASONE FUROATE	Jul 2028
FLONASE SENSIMIST ALLERGY RELIEF	FLUTICASONE FUROATE	Oct 2028
NICORETTE	NICOTINE POLACRILEX	Apr 2028
NICORETTE	NICOTINE POLACRILEX	Apr 2029
NICORETTE	NICOTINE POLACRILEX	Jun 2029

Catalogue

Marketed products

402

Showing 150 of 402.

Brand	Generic name	Form	Category
4 Way Fast Acting	Phenylephrine hydrochloride	SPRAY	OTC MONOGRAPH DRUG
ABREVA	docosanol	CREAM	NDA
ABREVA	docosanol	CREAM	ANDA
ABREVA Rapid Pain Relief	glycerin, lidocaine	GEL	OTC MONOGRAPH DRUG
ADVIL	ibuprofen	TABLET, COATED	NDA
ADVIL	ibuprofen	TABLET, COATED	NDA
ADVIL	ibuprofen	TABLET, COATED	NDA
ADVIL	ibuprofen	TABLET, COATED	NDA
ADVIL	ibuprofen	TABLET, COATED	NDA
ADVIL	ibuprofen	TABLET, COATED	NDA
ADVIL	ibuprofen	TABLET, COATED	NDA
ADVIL	ibuprofen	TABLET, COATED	NDA
ADVIL ALLERGY SINUS	chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl	TABLET, COATED	NDA
ADVIL COLD AND SINUS	ibuprofen and pseudoephedrine hydrochloride	TABLET, COATED	NDA
ADVIL COLD AND SINUS	ibuprofen, pseudoephedrine hydrochloride	CAPSULE, LIQUID FILLED	NDA
ADVIL COLD AND SINUS	ibuprofen and pseudoephedrine hydrochloride	TABLET, COATED	NDA
ADVIL DUAL ACTION WITH ACETAMINOPHEN	Ibuprofen, Acetaminophen	TABLET, FILM COATED	NDA
ADVIL DUAL ACTION WITH ACETAMINOPHEN Back Pain	Ibuprofen, Acetaminophen	TABLET, FILM COATED	NDA
ADVIL MIGRAINE	ibuprofen	CAPSULE, LIQUID FILLED	NDA
ADVIL PM	diphenhydramine HCl, ibuprofen	CAPSULE, LIQUID FILLED	NDA
ADVIL PM	diphenhydramine citrate and ibuprofen	TABLET, COATED	NDA
ADVIL PM	diphenhydramine HCl, ibuprofen	CAPSULE, LIQUID FILLED	NDA
ADVIL SINUS CONGESTION AND PAIN	ibuprofen, phenylephrine hydrochloride	TABLET, COATED	NDA
ALLI	orlistat	CAPSULE	NDA
AQUAFRESH CAVITY PROTECTION	sodium fluoride	PASTE	OTC MONOGRAPH DRUG
AQUAFRESH EXTRA FRESH PLUS WHITENING	sodium fluoride	PASTE	OTC MONOGRAPH DRUG
AQUAFRESH EXTREME CLEAN WHITENING ACTION	sodium fluoride	PASTE	OTC MONOGRAPH DRUG
AQUAFRESH SENSITIVE MAXIMUM STRENGTH	potassium nitrate and sodium fluoride	PASTE	OTC MONOGRAPH DRUG
-	Acetaminophen, aspirin, caffeine	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
Advil	ibuprofen sodium	TABLET, COATED	NDA
Advil	ibuprofen sodium	TABLET, COATED	NDA
Advil	ibuprofen	CAPSULE, LIQUID FILLED	NDA
Advil	ibuprofen	CAPSULE, LIQUID FILLED	NDA
Advil	ibuprofen	CAPSULE, LIQUID FILLED	NDA
Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	TABLET, COATED	NDA
Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	TABLET, COATED	NDA
Advil Menstrual Pain	ibuprofen sodium	TABLET, COATED	NDA
Advil Multi-Symptom Cold and Flu	chlorpheniramine maleate, ibuprofen, phenylephrine HCl	TABLET, COATED	NDA
Advil Targeted Relief	camphor, capsaicin, menthol, methyl salicylate	CREAM	OTC MONOGRAPH DRUG
Aquafresh Extreme Clean Pure Breath Action	sodium fluoride	PASTE	OTC MONOGRAPH DRUG
BIOTENE Fresh Mint Original	sodium fluoride	PASTE	OTC MONOGRAPH DRUG
BIOTENE Gentle Mint	sodium fluoride	PASTE	OTC MONOGRAPH DRUG
CHAPSTICK CLASSIC MEDICATED	camphor, menthol, petrolatum	STICK	OTC MONOGRAPH DRUG
CHILDRENS ADVIL	ibuprofen	SUSPENSION	NDA
CHILDRENS ADVIL	ibuprofen	SUSPENSION	NDA
CHILDRENS ADVIL	ibuprofen	SUSPENSION	NDA
CHILDRENS ADVIL	ibuprofen	SUSPENSION	NDA
CHILDRENS ADVIL	ibuprofen	SUSPENSION	NDA
CHILDRENS ADVIL	ibuprofen	SUSPENSION	NDA
CHILDRENS ADVIL	ibuprofen	SUSPENSION	NDA
CHILDRENS FLONASE ALLERGY RELIEF	fluticasone propionate	SPRAY, METERED	NDA
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING	chlorpheniramine maleate, dextrometrorphan HBr	LIQUID	OTC MONOGRAPH DRUG
CITRUCEL	methylcellulose	POWDER, FOR SOLUTION	OTC MONOGRAPH DRUG
CITRUCEL	methylcellulose	POWDER, FOR SOLUTION	OTC MONOGRAPH DRUG
CITRUCEL	methylcellulose	TABLET	OTC MONOGRAPH DRUG
ChapStick Classic Cherry	white petrolatum	STICK	OTC MONOGRAPH DRUG
ChapStick Classic Original	white petrolatum	STICK	OTC MONOGRAPH DRUG
ChapStick Classic Spearmint	white petrolatum	STICK	OTC MONOGRAPH DRUG
ChapStick Classic Spearmint	PETROLATUM	STICK	OTC MONOGRAPH DRUG
ChapStick Classic Strawberry	white petrolatum	STICK	OTC MONOGRAPH DRUG
ChapStick Supreme Classic Cherry	white petrolatum	STICK	OTC MONOGRAPH DRUG
Chapstick	avobenzone, octinoxate, and white petrolatum	KIT	OTC MONOGRAPH DRUG
Chapstick 12 Days of Christmas	white petrolatum	KIT	OTC MONOGRAPH DRUG
Chapstick 12 Days of Christmas	white petrolatum	KIT	OTC MONOGRAPH DRUG
Chapstick Active 2in1 Variety Pack	zinc oxide	KIT	OTC MONOGRAPH DRUG
Chapstick Holiday Classics Kit	white petrolatum	KIT	OTC MONOGRAPH DRUG
Chapstick Moisturizer Cool Mint	avobenzone, octinoxate, and white petrolatum	STICK	OTC MONOGRAPH DRUG
Chapstick Moisturizer Cool Mint	avobenzone, homosalate, octisalate, octocrylene, white petrolatum	STICK	OTC MONOGRAPH DRUG
Chapstick Moisturizer Original	avobenzone, octinoxate, and white petrolatum	STICK	OTC MONOGRAPH DRUG
Chapstick Moisturizer Original	avobenzone, homosalate, octisalate, octocrylene, white petrolatum	STICK	OTC MONOGRAPH DRUG
Chapstick Moisturizer Variety Pack	avobenzone, homosalate, octisalate, octocrylene, white petrolatum	KIT	OTC MONOGRAPH DRUG
Chapstick Total Hydration Moisture Tint Peachy Keen	zinc oxide	STICK	OTC MONOGRAPH DRUG
Chapstick Total Hydration Moisture Tint Pretty in Pink	zinc oxide	STICK	OTC MONOGRAPH DRUG
Chapstick Total Hydration Moisture Tint Very Berry	zinc oxide	STICK	OTC MONOGRAPH DRUG
Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE	ANDA
Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE	ANDA
Childrens Robitussin Cough Long-Acting	dextromethorphan hydrobromide	LIQUID	OTC MONOGRAPH DRUG
Childrens Robitussin Cough and Chest Congestion DM	dextromethorphan hydrobromide and guaifenesin	LIQUID	OTC MONOGRAPH DRUG
Childrens Robitussin Cough and Chest Congestion DM	dextromethorphan hydrobromide, guaifenesin	LIQUID	OTC MONOGRAPH DRUG
Childrens Robitussin Cough and Cold CF	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	LIQUID	OTC MONOGRAPH DRUG
Childrens Robitussin Elderberry Cough and Chest Congestion DM	dextromethorphan HBr, guaifenesin	SOLUTION	OTC MONOGRAPH DRUG
Childrens Robitussin Honey Cough and Chest Congestion DM	dextromethorphan HBr, guaifenesin	SOLUTION	OTC MONOGRAPH DRUG
Childrens Robitussin Honey Nighttime Cough DM	dextromethorphan hbr, doxylamine succinate	SOLUTION	OTC MONOGRAPH DRUG
Childrens Robitussin Nighttime Cough Long-Acting DM	chlorpheniramine maleate, dextromethorphan hydrobromide	SOLUTION	OTC MONOGRAPH DRUG
-	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride	SYRUP	EXPORT ONLY
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE	SENNOSIDES	PILL	OTC MONOGRAPH DRUG
EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE	SENNOSIDES	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE	SENNOSIDES	TABLET	OTC MONOGRAPH DRUG
EXCEDRIN MIGRAINE	Acetaminophen, Aspirin (NSAID) and Caffeine	TABLET, FILM COATED	NDA
EXCEDRIN MIGRAINE	Acetaminophen, Aspirin (NSAID) and Caffeine	TABLET, FILM COATED	NDA
Excedrin Extra Strength Geltabs	Acetaminophen, Asprin, Caffeine	TABLET, COATED	OTC MONOGRAPH DRUG
Excedrin Extra Strength Headache	Acetaminophen, Aspirin (NSAID), Caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
Excedrin Extra Strength Headache	Acetaminophen, Aspirin (NSAID), Caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
Excedrin Extra Strength Pain Reliever	Acetaminophen, Aspirin (NSAID), and Caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
Excedrin Extra Strength Pain Reliever	Acetaminophen, Aspirin (NSAID), and Caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
Excedrin Extra Strength Pain Reliever	Acetaminophen, Aspirin (NSAID), and Caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
Excedrin Extra Strength Pain Reliever	Acetaminophen, Aspirin (NSAID), and Caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
Excedrin Extra Strength and Excedrin Tension Headache	Acetaminophen, Aspirin (NSAID), and Caffeine	KIT	OTC MONOGRAPH DRUG
Excedrin Migraine	Acetaminophen, Aspirin, and Caffeine	TABLET, FILM COATED	NDA
Excedrin Migraine Geltabs	Acetaminophen, Asprin, Caffeine	TABLET, COATED	NDA
Excedrin Migraine Relief	Acetaminophen, Aspirin (NSAID), Caffeine	TABLET, FILM COATED	NDA
Excedrin PM Triple Action Caplets	Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate	TABLET, COATED	OTC MONOGRAPH DRUG
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever	Acetaminophen, Aspirin (NSAID), Caffeine, and Diphenhydramine Citrate	KIT	OTC MONOGRAPH DRUG
Excedrin PM Triple Action Caplets and Excedrin Tension Headache	Acetaminophen, Aspirin (NSAID), Caffeine, and Diphenhydramine Citrate	KIT	OTC MONOGRAPH DRUG
Excedrin Rapid Relief	acetaminophen	TABLET	OTC MONOGRAPH DRUG
Excedrin Tension Headache	Acetaminophen, Caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
FLONASE ALLERGY RELIEF	fluticasone propionate	SPRAY, METERED	NDA
FLONASE Headache and Allergy Relief	acetaminophen, chlorpheniramine maleate, phenylephrine hcl	TABLET	OTC MONOGRAPH DRUG
FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED	NDA
FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED	NDA
GAVISCON	aluminum hydroxide and magnesium carbonate	LIQUID	OTC MONOGRAPH DRUG
GAVISCON	aluminum hydroxide and magnesium carbonate	LIQUID	OTC MONOGRAPH DRUG
GAVISCON	aluminum hydroxide and magnesium carbonate	LIQUID	OTC MONOGRAPH DRUG
Gas-X Extra Strength	Simethicone	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Gas-X Extra Strength	Simethicone	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Gas-X Extra Strength Softgels	Simethicone	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Gas-X Maximum Strength Softgels	Simethicone	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Gas-X Total Relief Maximum Strength	Calcium carbonate, Simethicone	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Gas-X Total Relief Maximum Strength	Calcium carbonate, Simethicone	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Gas-X Ultimate Strength Softgels	Simethicone	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Gas-X Ultra Strength AntiGas Softgels	Simethicone	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Gaviscon Extra Strength	aluminum hydroxide and magnesium carbonate	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Gaviscon Extra Strength	aluminum hydroxide and magnesium carbonate	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
INFANTS ADVIL	ibuprofen	SUSPENSION/ DROPS	NDA
-	Ibuprofen	TABLET, COATED	DRUG FOR FURTHER PROCESSING
JUNIOR STRENGTH ADVIL	ibuprofen	TABLET, COATED	NDA
JUNIOR STRENGTH ADVIL	ibuprofen	TABLET, CHEWABLE	NDA
NATEAN Clean and Whiten	sodium fluoride	PASTE	OTC MONOGRAPH DRUG
NATEAN Clean plus Sensitivity Relief	potassium nitrate, sodium fluoride	PASTE	OTC MONOGRAPH DRUG
NICODERM CQ	nicotine	PATCH, EXTENDED RELEASE	NDA
NICODERM CQ	nicotine	PATCH, EXTENDED RELEASE	NDA
NICODERM CQ	nicotine	PATCH, EXTENDED RELEASE	NDA
NICORETTE	nicotine polacrilex	LOZENGE	NDA
NICORETTE	nicotine polacrilex	LOZENGE	NDA
NICORETTE	nicotine polacrilex	LOZENGE	NDA
NICORETTE	nicotine polacrilex	LOZENGE	NDA
NICORETTE	nicotine polacrilex	LOZENGE	NDA
NICORETTE	nicotine polacrilex	LOZENGE	ANDA
NICORETTE	nicotine polacrilex	LOZENGE	ANDA
NICORETTE	nicotine polacrilex	LOZENGE	NDA
NICORETTE	nicotine polacrilex	LOZENGE	NDA
Nexium 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE	NDA
Nexium 24HR	esomeprazole magnesium	TABLET	NDA
Nexium 24HR ClearMinis	esomeprazole magnesium	CAPSULE, DELAYED RELEASE	NDA
Nicorette Cherry Peppermint	nicotine polacrilex	LOZENGE	NDA
Nicorette Cherry Peppermint	nicotine polacrilex	LOZENGE	NDA
Nicorette Cinnamon Surge	nicotine polacrilex	GUM, CHEWING	NDA
Nicorette Cinnamon Surge	nicotine polacrilex	GUM, CHEWING	NDA
Nicorette Fruit Chill	nicotine polacrilex	GUM, CHEWING	NDA
Nicorette Fruit Chill	nicotine polacrilex	GUM, CHEWING	NDA

Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.