Labeler · US market

Reckitt Benckiser LLC

Reckitt Benckiser LLC is a US drug labeler with US FDA registrations covering 97 drug concepts (96 currently active) across 313 packages. It is currently the only active US supplier of 30+ drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Reckitt Benckiser

ACTIVE — US

openFDA · updated weekly

Labeler codes59316 · 63824 · 72854

Active drugs96

Registrations173 active / 174

Packages313

Sole supplier of30+ drugs

Portfolio97 drugs · US

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

Drug	Type	NDCs	Packages	Status
Menthol gel	otc	9	34	SUPPLYING
Guaifenesin tablet, extended release	rx	2	19	SUPPLYING
Guaifenesin And Dextromethorphan Hydrobromide tablet, extended release	otc	2	14	SUPPLYING
Menthol, Unspecified Form gel	otc	4	12	SUPPLYING
Dextromethorphan suspension, extended release	otc	4	11	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride capsule, liquid filled	otc	6	10	SUPPLYING
Menthol spray	otc	4	10	SUPPLYING
Menthol, Unspecified Form patch	otc	2	10	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride kit	otc	7	9	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride tablet, film coated	otc	3	6	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride solution	otc	5	6	SUPPLYING
Dextromethorphan Hydrobromide And Guaifenesin solution	otc	5	6	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide tablet	otc	2	5	SUPPLYING
Hexylresorcinol lozenge	otc	2	5	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride solution	otc	4	4	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide capsule, liquid filled	otc	2	4	SUPPLYING
Menthol cream	otc	3	4	SUPPLYING
Acetaminophen, Guaifenesin tablet, film coated	otc	1	4	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride solution	otc	1	4	SUPPLYING
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride solution	otc	3	4	SUPPLYING
Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride tablet, film coated	otc	1	4	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, And Triprolidine Hydrochloride kit	otc	1	3	SUPPLYING
Guaifenesin And Pseudoephedrine Hydrochloride tablet, extended release	otc	2	3	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, And Triprolidine Hydrochloride solution	otc	2	3	SUPPLYING
Menthol liquid	otc	2	3	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Triprolidine Hydrochloride kit	otc	1	3	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate kit	otc	1	3	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride tablet, coated	otc	2	3	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride tablet, coated	otc	1	3	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride capsule, liquid filled	otc	3	3	SUPPLYING
Menthol kit	otc	3	3	SUPPLYING
Oxymetazoline Hydrochloride solution	otc	3	3	SUPPLYING
Naproxen Sodium, Dextromethorphan Hydrobromide, Guaifenesin tablet, extended release	otc	1	3	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Triprolidine Hydrochloride kit	otc	1	3	SUPPLYING
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride suspension	otc	2	2	SUPPLYING
Acetaminophen, Dextromethorphan Hydrobromide, And Triprolidine Hydrochloride tablet, coated	otc	2	2	SUPPLYING
Lidocaine patch	rx	1	2	SUPPLYING
Lidocaine, Menthol patch	rx	1	2	SUPPLYING
Benzoyl Peroxide cream	rx	2	2	SUPPLYING
Menthol patch	otc	1	2	SUPPLYING

Showing 40 of 97 drugs by package count.

Sole US supplier

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

+20+ more

At a glance

TypeLabeler
Labeler codes59316, 63824, 72854
Filing names2
Drugs (active)96
Drugs (all time)97
US registrations174
Packages313

Recent events

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

Aug 3, 2016
RECALLRecall (Class III): Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 638…
Apr 15, 2015
RECALLRecall (Class I): Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan…
Apr 15, 2015
RECALLRecall (Class II): Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12…
Apr 15, 2015
RECALLRecall (Class I): Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HC…
Apr 15, 2015
RECALLRecall (Class I): Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl o…
Apr 15, 2015
RECALLRecall (Class I): Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bot…
Apr 15, 2015
RECALLRecall (Class I): Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expec…
Apr 15, 2015
RECALLRecall (Class I): Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Ph…

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.