Labeler · US market

Sato Pharmaceutical Co., Ltd.

Sato Pharmaceutical Co., Ltd. is a US drug labeler with US FDA registrations covering 31 drug concepts (31 currently active) across 35 packages. It is currently the only active US supplier of 13 drugs. The company files with FDA under 3 name variants, merged into this profile.

Also files as: Sato Pharmaceutical Inc., Ltd. · Sato Pharmaceuticals Co., Ltd.

ACTIVE — US

openFDA · updated weekly

Labeler codes49873

Active drugs31

Registrations33 active / 33

Packages35

Sole supplier of13 drugs

Portfolio31 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Dl-Camphor, L-Menthol, Methyl Salicylate patch	otc	2	4	SUPPLYING
Camphor, Capsaicin, Menthol patch	otc	2	2	SUPPLYING
Capsaicin patch	otc	1	1	SUPPLYING
Dimenhydrinate tablet	otc	1	1	SUPPLYING
Meclizine Hydrochloride tablet	rx	1	1	SUPPLYING
Docusate Sodium, Sennosides tablet	otc	1	1	SUPPLYING
Magnesium Aluminosilicate, Magnesium Hydroxide solution	otc	1	1	SUPPLYING
Benzalkonium Chloride, Lidocaine Hydrochloride spray	otc	1	1	SUPPLYING
Tolnaftate solution	otc	1	1	SUPPLYING
Lidocaine Hydrochloride lotion	rx	1	1	SUPPLYING
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride tablet	otc	1	1	SUPPLYING
Dextromethorphan Hydrobromide, Guaifenesin syrup	otc	1	1	SUPPLYING
Tolnaftate ointment	otc	1	1	SUPPLYING
Methyl Salicylate, Dl-Camphor, L-Menthol lotion	otc	1	1	SUPPLYING
Dextromethorphan Hydrobromide lozenge	otc	1	1	SUPPLYING
Lidocaine, Menthol cream	otc	1	1	SUPPLYING
Naphazoline Hydrochloride liquid	otc	1	1	SUPPLYING
Hydrocortisone Acetate ointment	otc	1	1	SUPPLYING
Methyl Salicylate, Dl-Camphor, L-Menthol spray	otc	1	1	SUPPLYING
Diphenhydramine Hydrochloride, Levomenthol gel	otc	1	1	SUPPLYING
Glycerin enema	otc	1	1	SUPPLYING
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide syrup	otc	1	1	SUPPLYING
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride capsule	otc	1	1	SUPPLYING
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride tablet	otc	1	1	SUPPLYING
Camphor, Menthol, Methyl Salicylate lotion	otc	1	1	SUPPLYING
Diphenhydramine Hydrochloride, Menthol cream	otc	1	1	SUPPLYING
Aluminum Hydroxide, Magnesium Carbonate, Sodium Bicarbonate granule	otc	1	1	SUPPLYING
Chlorpheniramine Maleate, Phenylephrine tablet	otc	1	1	SUPPLYING
Salicylic Acid liquid	rx	1	1	SUPPLYING
Magnesium Aluminosilicates, Magnesium Hydroxide, Simethicone tablet	otc	1	1	SUPPLYING
Acetaminophen tablet	otc	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

+3 more

At a glance

TypeLabeler
Labeler codes49873
Filing names3
Drugs (active)31
Drugs (all time)31
US registrations33
Packages35

Recent events

Shortages, recalls, and registration changes across all filing names.

Dec 19, 2025
RECALLRecall (Class II): INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufacture…
Oct 1, 2019
RECALLRecall (Class III): Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S.…
Oct 1, 2019
RECALLRecall (Class III): WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3 11917-18328 2 ) an…
Oct 1, 2019
RECALLRecall (Class III): Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Wes…
Oct 1, 2019
RECALLRecall (Class III): Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 206…
Oct 1, 2019
RECALLRecall (Class III): Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured b…
Feb 16, 2017
RECALLRecall (Class II): DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuti…
Feb 16, 2017
RECALLRecall (Class II): Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmace…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.