Labeler · US market

Guardian Drug Company

Guardian Drug Company is a US drug labeler with US FDA registrations covering 21 drug concepts (21 currently active) across 68 packages. It is currently the only active US supplier of 2 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes53041

Active drugs21

Registrations45 active / 45

Packages68

Sole supplier of2 drugs

Portfolio21 drugs · US

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

Drug	Type	NDCs	Packages	Status
Guaifenesin tablet, extended release	rx	4	14	SUPPLYING
Ibuprofen suspension/ drops	otc	6	10	SUPPLYING
Calcium Carbonate tablet, chewable	otc	8	9	SUPPLYING
Bismuth Subsalicylate liquid	otc	3	6	SUPPLYING
Potassium Chloride solution	rx	2	4	SUPPLYING
Diatrizoate Meglumine And Diatrizoate Sodium solution	rx	2	3	SUPPLYING
Potassium Chloride powder, for solution	rx	1	2	SUPPLYING
Acteaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl liquid	otc	2	2	SUPPLYING
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl liquid	otc	2	2	SUPPLYING
Omeprazole, Sodium Bicarbonate capsule	rx	2	2	SUPPLYING
Sennosides tablet	otc	1	2	SUPPLYING
Bismuth Subsalicylate tablet, chewable	otc	2	2	SUPPLYING
Simethicone tablet, chewable	otc	2	2	SUPPLYING
Acteaminophen, Guaifenesin, Phenylephrine Hcl liquid	otc	1	1	SUPPLYING
Levetiracetam solution	rx	1	1	SUPPLYING
Diphenhydramine Hcl liquid	otc	1	1	SUPPLYING
Dextromethorphan Hbr, Guaifenesin liquid	otc	1	1	SUPPLYING
Esomeprazole Magnesium capsule, delayed release	rx	1	1	SUPPLYING
Loperamide Hydrochloride, Simethicone tablet	otc	1	1	SUPPLYING
Calcium Polycarbophil tablet, film coated	otc	1	1	SUPPLYING
Brompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl liquid	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.

At a glance

TypeLabeler
Labeler codes53041
Filing names1
Drugs (active)21
Drugs (all time)21
US registrations45
Packages68

Recent events

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

May 28, 2026
RECALLRecall (Class II): Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Ame…
May 28, 2026
RECALLRecall (Class II): FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOO…
May 28, 2026
RECALLRecall (Class II): H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE …
May 28, 2026
RECALLRecall (Class II): TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASS…
May 28, 2026
RECALLRecall (Class II): HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST D…
May 28, 2026
RECALLRecall (Class II): CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A…
May 28, 2026
RECALLRecall (Class II): KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRU…
May 28, 2026
RECALLRecall (Class II): CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A,…

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; figures cover the entity across all its filing names.