Labeler · US market

Efficient Laboratories Inc

Efficient Laboratories Inc is a US drug labeler with US FDA registrations covering 19 drug concepts (16 currently active) across 26 packages. It is currently the only active US supplier of 3 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes58593

Active drugs16

Registrations19 active / 23

Packages26

Sole supplier of3 drugs

Portfolio19 drugs · US

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

Drug	Type	NDCs	Packages	Status
Guaifenesin liquid	otc	3	4	SUPPLYING
Tolnaftate cream	otc	1	3	SUPPLYING
Brompheniramine Maleate, Dextromethorphan Hbr liquid	otc	2	2	SUPPLYING
Dextromethorphan Hbr, Guaifenesin liquid	otc	2	2	SUPPLYING
Benzocaine, Glycerin liquid	otc	1	1	SUPPLYING
Undecylenic Acid liquid	otc	1	1	SUPPLYING
Tolnaftate liquid	rx	1	1	SUPPLYING
Acetaminophen, Dextromethorphan Hbr, Guaifenesin liquid	otc	1	1	SUPPLYING
Dextromethorphan liquid	otc	1	1	SUPPLYING
Acetaminophen Dextromethorphan Hbr Doxylamine Succinate liquid	otc	1	1	SUPPLYING
Undecylenic Acid spray	otc	1	1	SUPPLYING
Tolnaftate powder	otc	1	1	SUPPLYING
Tolnaftate aerosol, spray	otc	1	1	SUPPLYING
Tolnaftate aerosol, powder	otc	1	1	SUPPLYING
Benzocaine spray	otc	1	1	SUPPLYING
Acetaminophen, Dextromethophan Hbr, Phenylephrine Hcl, Guaifenesin liquid	otc	1	1	SUPPLYING
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl liquid	otc	1	1	DISCONTINUED
Dextromethorphan, Brompheniramine Maleate, Phenylephrine Hydrochloride liquid	otc	1	1	DISCONTINUED
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl liquid	otc	1	1	DISCONTINUED

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 codes58593
Filing names1
Drugs (active)16
Drugs (all time)19
US registrations23
Packages26

Recent events

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

Aug 24, 2021
RECALLRecall (Class II): Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06
Aug 24, 2021
RECALLRecall (Class II): Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. M…
Aug 24, 2021
RECALLRecall (Class II): Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, In…
Aug 24, 2021
RECALLRecall (Class II): Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottl…
Jan 31, 2020
RECALLRecall (Class II): Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL …
Jan 31, 2020
RECALLRecall (Class II): Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UP…
Jan 31, 2020
RECALLRecall (Class II): New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 3…

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.