Is Time Cap Laboratories, Inc. FDA approved?

Time Cap Laboratories, Inc. holds 1 FDA-registered establishment in the United States. 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 Time Cap Laboratories, Inc.'s drugs manufactured?

The FDA register lists FARMINGDALE, NY. Registered operations: finished drug manufacture.

What drugs does Time Cap Laboratories, Inc. make?

88 products are listed under Time Cap Laboratories, Inc. in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule, liquid filled. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Time Cap Laboratories, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 88
Labeller names: 11
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Time Cap Laboratories, Inc.	7 Michael Avenue, FARMINGDALE, New York (NY) 11735, United States (USA)	Finished drug manufacture	2431898037052099

Catalogue

Drug listings by form and route

88 active NDC listings: 61 human otc drug, 27 human prescription drug. By marketing category: ANDA 46, OTC MONOGRAPH DRUG 24, OTC MONOGRAPH FINAL 12, OTC MONOGRAPH NOT FINAL 3, UNAPPROVED DRUG OTHER 3.

Dosage form	NDCs
tablet	23
tablet, film coated	22
capsule, liquid filled	10
capsule	9
tablet, delayed release	7
tablet, coated	6
tablet, extended release	4
kit	2
tablet, chewable	2
tablet, sugar coated	2
capsule, delayed release	1

Route	NDCs
oral	87

Labeller name on the listing	NDCs
time cap laboratories, inc	30
time cap laboratories, inc.	25
time-cap labs, inc	11
time cap laboratories,inc	8
time cap labs inc	5
time cap laboratories	3
time cap labs, inc	2
time cap laboratories inc	1
time cap laboratories inc.	1
time cap labs	1
time cap labs inc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ACETAMINOPHEN	ACETAMINOPHEN	tablet, oral	49483-340OTC MONOGRAPH DRUG
ACETAMINOPHEN	ACETAMINOPHEN	tablet, film coated, oral	49483-342OTC MONOGRAPH NOT FINAL
ACETAMINOPHEN Extra Strength	ACETAMINOPHEN	tablet, film coated, oral	49483-341OTC MONOGRAPH DRUG
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	tablet, film coated, oral	49483-061OTC MONOGRAPH DRUG
ASPIRIN	ASPIRIN	tablet, coated, oral	49483-011OTC MONOGRAPH DRUG
ASPIRIN EXTRA STRENGTH	Aspirin	tablet, coated, oral	49483-382OTC MONOGRAPH FINAL
Acetaminophen	Acetaminophen tablet extended release	tablet, extended release, oral	49483-699ANDA
Alert	Caffeine	tablet, film coated, oral	49483-343OTC MONOGRAPH FINAL
Allergy Time	Chlorpheniramine Maleate	tablet, oral	49483-242OTC MONOGRAPH FINAL
Aspirin Delayed Release	Aspirin	tablet, delayed release, oral	49483-349OTC MONOGRAPH FINAL
Benzonatate 100 mg	Benzonatate	capsule, liquid filled, oral	49483-946ANDA
Benzonatate 200 mg	Benzonatate	capsule, liquid filled, oral	49483-947ANDA
Cetirizine Hydrochloride	Cetirizine Hydrochloride	tablet, oral	49483-682ANDA
Cetirizine Hydrochloride Tablets,10 mg	Cetirizine Hydrochloride	tablet, oral	49483-692ANDA
Comfort-Time	Acetaminophen, Caffeine, and Pyrilamine Maleate	tablet, film coated, oral	49483-347OTC MONOGRAPH NOT FINAL
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	tablet, coated, oral	49483-329OTC MONOGRAPH FINAL
Daytime Nighttime Cold and Flu	Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI, Doxylamine Succinate 325, 10/15, 5, 6.25 mg softgels	kit, oral	49483-695OTC MONOGRAPH DRUG
Daytime cold and flu	Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI 325, 10, 5 mg softgels	capsule, liquid filled, oral	49483-693OTC MONOGRAPH DRUG
Dual Action Pain Relief	Acetaminophen, Ibuprofen	tablet, oral	49483-716ANDA
EXTRA PAIN RELIEF	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	tablet, film coated, oral	49483-370OTC MONOGRAPH DRUG
EXTRA STRENGTH ACETAMINOPHEN	Acetaminophen	tablet, oral	49483-697OTC MONOGRAPH DRUG
Enteric Coated Aspirin Regular Strength	Aspirin	tablet, delayed release, oral	49483-331OTC MONOGRAPH DRUG
Esomeprazole magnesium	esomeprazole magnesium	capsule, delayed release, oral	49483-718ANDA
Extra Strength Acetaminophen	Acetaminophen	tablet, oral	49483-673OTC MONOGRAPH DRUG
Extra Strength Acetaminophen	Acetaminophen	tablet, oral	83934-673OTC MONOGRAPH DRUG
Extra strength Acetaminophen PM	Acetaminophen 500mg/ Diphenhydramine HCl 25mg	tablet, oral	49483-430OTC MONOGRAPH DRUG
Fluoxetine	Fluoxetine Hydrochloride	capsule, oral	49483-701ANDA
Fluoxetine	Fluoxetine Hydrochloride	capsule, oral	49483-702ANDA
Fluoxetine	Fluoxetine Hydrochloride	capsule, oral	49483-703ANDA
GABAPENTIN	gabapentin	capsule, oral	49483-605ANDA
GABAPENTIN	GABAPENTIN	capsule, oral	49483-606ANDA
GABAPENTIN	GABAPENTIN	capsule, oral	49483-607ANDA
Guaifenesin Extended Release 1200 mg	Guaifenesin	tablet, oral	49483-724ANDA
Guaifenesin Extended Release 600 mg	Guaifenesin	tablet, oral	49483-723ANDA
IBUPROFEN	IBUPFROFEN	tablet, film coated, oral	49483-600ANDA
IBUPROFEN	IBUPROFEN	tablet, film coated, oral	49483-601ANDA
IBUPROFEN	IBUPROFEN	capsule, liquid filled, oral	49483-610ANDA
IBUPROFEN	IBUPROFEN	tablet, film coated, oral	49483-611ANDA
IBUPROFEN	IBUPROFEN	tablet, film coated, oral	49483-612ANDA
Ibuprofen	Ibuprofen	tablet, film coated, oral	49483-114ANDA
Ibuprofen	Ibuprofen Capsules 200 mg	capsule, liquid filled, oral	49483-133ANDA
Ibuprofen	Ibuprofen	tablet, film coated, oral	49483-602ANDA
Ibuprofen	Ibuprofen	tablet, film coated, oral	49483-603ANDA
Ibuprofen	Ibuprofen	tablet, film coated, oral	49483-604ANDA
Ibuprofen	Ibuprofen	capsule, liquid filled, oral	49483-700ANDA
LAX-TIME	SENNOSIDES	tablet, sugar coated, oral	49483-083OTC MONOGRAPH DRUG
LORATADINE	LORATADINE	capsule, liquid filled, oral	49483-686ANDA
LOW DOSE ASPIRIN	ASPIRIN	tablet, coated, oral	49483-481OTC MONOGRAPH DRUG
Loratadine 10 mg	Loratadine Tablets USP, 10 mg	tablet, oral	49483-732ANDA
Low Dose Aspirin Enteric Safety Coated	Aspirin	tablet, delayed release, oral	49483-328OTC MONOGRAPH FINAL
Low Dose Aspirin Enteric Safety Coated	Aspirin	tablet, delayed release, oral	49483-381OTC MONOGRAPH FINAL
Low Dose Miniprin Enteric Safety Coated	Aspirin	tablet, delayed release, oral	49483-330OTC MONOGRAPH FINAL
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	Metformin Hydrochloride	tablet, extended release, oral	49483-623ANDA
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	Metformin Hydrochloride	tablet, extended release, oral	49483-624ANDA
MUCOSA	GUAIFENESIN	tablet, oral	49483-272OTC MONOGRAPH DRUG
MUCOSA DM	GUAIFENESIN DEXTROMETHORPHAN	tablet, oral	49483-280OTC MONOGRAPH DRUG
Maximum Strength Acid Reducer	Famotidine	tablet, oral	49483-720ANDA
Maximum strength Day cold and flu and Night severe cold and flu	Acetaminophe, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Triprolidine HCl Tablets	kit	49483-726OTC MONOGRAPH DRUG
Metformin HCl	Metformin HCl	tablet, film coated, oral	49483-620ANDA
Metformin HCl	Metformin HCl	tablet, film coated, oral	49483-621ANDA
Metformin HCl	Metformin HCl	tablet, film coated, oral	49483-622ANDA
Motion-Time Chewable	Meclizine HCl	tablet, chewable, oral	49483-333OTC MONOGRAPH FINAL
Muscle Aches and Pains Acetaminophen extended release	Acetaminophen	tablet, extended release, oral	49483-704ANDA
NAPROXEN	NAPROXEN	tablet, oral	49483-617ANDA
NAPROXEN	NAPROXEN	tablet, oral	49483-618ANDA
NAPROXEN	NAPROXEN	tablet, oral	49483-619ANDA
NAPROXEN SODIUM	NAPROXEN SODIUM	tablet, film coated, oral	49483-608ANDA
NAPROXEN SODIUM	NAPROXEN SODIUM	tablet, film coated, oral	49483-609ANDA
NITRO-TIME	NITROGLYCERIN	capsule, oral	49483-221UNAPPROVED DRUG OTHER
NITRO-TIME	NITROGLYCERIN	capsule, oral	49483-222UNAPPROVED DRUG OTHER
NITRO-TIME	NITROGLYCERIN	capsule, oral	49483-223UNAPPROVED DRUG OTHER
Omeprazole delayed release	Omeprazole 20mg	tablet, delayed release, oral	49483-731ANDA
PSEUDO TIME PE	PHENYLEPHRINE HCHLORIDE	tablet, film coated, oral	49483-234OTC MONOGRAPH FINAL
Pain Reliever Dye Free	Acetaminophen	tablet, oral	49483-479OTC MONOGRAPH DRUG
Paricalcitol	Paricalcitol	capsule, liquid filled, oral	49483-687ANDA
Paricalcitol	Paricalcitol	capsule, liquid filled, oral	49483-688ANDA
Paricalcitol	Paricalcitol	capsule, liquid filled, oral	49483-689ANDA
SENNA TIME	SENNOSIDES	tablet, coated, oral	49483-080OTC MONOGRAPH DRUG
SENNA TIME S	DOCUSATE SODIUM-SENNOSIDES	tablet, film coated, oral	49483-081OTC MONOGRAPH DRUG
SENNOSIDES	SENNOSIDES	tablet, sugar coated, oral	49483-079OTC MONOGRAPH DRUG
SENNOSIDES AND DOCUSATE SODIUM	SENNOSIDES AND DOCUSATE SODIUM	tablet, film coated, oral	49483-097OTC MONOGRAPH DRUG
STIMULANT LAXATIVE	BISACODYL	tablet, delayed release, oral	49483-003OTC MONOGRAPH NOT FINAL
Tension Headache Relief	Acetaminophen, Caffeine	tablet, oral	49483-373OTC MONOGRAPH DRUG
Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	tablet, oral	49483-690ANDA
Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	tablet, oral	49483-691ANDA
aspirin low dose chewable	aspirin	tablet, chewable, oral	49483-334OTC MONOGRAPH DRUG
aspirin low dose enteric coated	aspirin	tablet, coated, oral	49483-387OTC MONOGRAPH FINAL
aspirin low dose enteric coated	aspirin	tablet, oral	49483-390OTC MONOGRAPH FINAL

Neighbours

Registered in the same town

ABBE Laboratories, Inc.Farmingdale, NY
Pharbest Pharmaceuticals, Inc.Farmingdale, NY

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Enquiry

Common questions

Is Time Cap Laboratories, Inc. FDA approved?: Time Cap Laboratories, Inc. holds 1 FDA-registered establishment in the United States. 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 Time Cap Laboratories, Inc.'s drugs manufactured?: The FDA register lists FARMINGDALE, NY. Registered operations: finished drug manufacture.
What drugs does Time Cap Laboratories, Inc. make?: 88 products are listed under Time Cap Laboratories, Inc. in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule, liquid filled. 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.