Is Kramer Laboratories FDA approved?

Kramer Laboratories holds no registered establishment of its own; 26 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Kramer Laboratories make?

26 products are listed under Kramer Laboratories in the openFDA NDC Directory, most often as liquid; shampoo; cream. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Kramer Laboratories

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

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Registered sites: 0
Active NDC listings: 26
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

26 active NDC listings: 26 human otc drug. By marketing category: OTC MONOGRAPH DRUG 22, NDA 3, ANDA 1.

Dosage form	NDCs
liquid	10
shampoo	5
cream	2
tablet	2
aerosol, foam	1
aerosol, spray	1
ointment	1
solution	1
spray	1
tablet, chewable	1
tablet, coated	1

Route	NDCs
topical	14
oral	12

Labeller name on the listing	NDCs
kramer laboratories	20
kramer laboratories	6

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
EXTRA STRENGTH gas relief	SIMETHICONE	liquid, oral	55505-225OTC MONOGRAPH DRUG
Fungi Nail Anti-Fungal Pen	Tolnaftate	liquid, topical	55505-193OTC MONOGRAPH DRUG
Fungi Nail Everyday Antifungal Powder	Tolnaftate	spray, topical	55505-234OTC MONOGRAPH DRUG
Fungi Nail Toe and Foot	Tolnaftate	solution, topical	55505-177OTC MONOGRAPH DRUG
Fungi Nail Toe and Foot	Tolnaftate	ointment, topical	55505-185OTC MONOGRAPH DRUG
HC Max Anti-Fungal	Tolnaftate	aerosol, spray, topical	55505-195OTC MONOGRAPH DRUG
Kaopectate	Bismuth subsalicylate	tablet, coated, oral	55505-197OTC MONOGRAPH DRUG
Kaopectate	Bismuth subsalicylate	tablet, chewable, oral	55505-206OTC MONOGRAPH DRUG
Kaopectate	Bismuth Subsalicylate	liquid, oral	55505-229OTC MONOGRAPH DRUG
Kaopectate Max Peppermint Flavor Anti Diarrheal	bismuth subsalicylate	liquid, oral	55505-200OTC MONOGRAPH DRUG
Kaopectate Peppermint Flavor Anti Diarrheal	bismuth subsalicylate	liquid, oral	55505-199OTC MONOGRAPH DRUG
Kaopectate Vanilla Flavor Anti Diarrheal	bismuth subsalicylate	liquid, oral	55505-198OTC MONOGRAPH DRUG
Nizoral	Ketoconazole	shampoo, topical	55505-196NDA
Nizoral	Ketoconazole	shampoo, topical	55505-232NDA
Nizoral	Ketoconazole	shampoo, topical	55505-233NDA
Nizoral Eczema Relief Cream	Colloidal Oatmeal	cream, topical	55505-223OTC MONOGRAPH DRUG
Nizoral Hair Regrowth Treatment for Men	Minoxidil	aerosol, foam, topical	55505-237ANDA
Nizoral Psoriasis	Salicylic Acid	shampoo, topical	55505-202OTC MONOGRAPH DRUG
Nizoral Psoriasis Relief	Salicylic Acid	cream, topical	55505-224OTC MONOGRAPH DRUG
Nizoral Scalp Itch Relief	HYDROCORTISONE	shampoo, topical	55505-222OTC MONOGRAPH DRUG
Opti-Nail 2-in-1	Tolnaftate	liquid, topical	55505-219OTC MONOGRAPH DRUG
SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin	tablet, oral	55505-230OTC MONOGRAPH DRUG
SAFETUSSIN Non Drowsy Cough plus chest congestion	Dextromethorphan Hydrobromide, and Guaifenesin	liquid, oral	55505-220OTC MONOGRAPH DRUG
SAFETUSSIN Non Drowsy Cough plus chest congestion	Dextromethorphan Hydrobromide, and Guaifenesin	tablet, oral	55505-231OTC MONOGRAPH DRUG
Safetussin High Blood Pressure and diabetes Cough, Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin	liquid, oral	55505-217OTC MONOGRAPH DRUG
Safetussin PM Nighttime Cough relief	Dextromethorphan HBr, Doxylamine Succinate	liquid, oral	55505-221OTC MONOGRAPH DRUG

Compare

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Enquiry

Common questions

Is Kramer Laboratories FDA approved?: Kramer Laboratories holds no registered establishment of its own; 26 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Kramer Laboratories make?: 26 products are listed under Kramer Laboratories in the openFDA NDC Directory, most often as liquid; shampoo; cream. 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.