Labeler · US market

Prestige Brands Holdings, Inc.

Prestige Brands Holdings, Inc. is a US drug labeler with US FDA registrations covering 20 drug concepts (20 currently active) across 51 packages. It is currently the only active US supplier of 11 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes52183 · 67172

Active drugs20

Registrations42 active / 42

Packages51

Sole supplier of11 drugs

Portfolio20 drugs · US

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

Drug	Type	NDCs	Packages	Status
Pectin lozenge	otc	9	13	SUPPLYING
Naphazoline Hydrochloride And Glycerin liquid	otc	3	6	SUPPLYING
Phenol spray	otc	5	5	SUPPLYING
Menthol And Benzocaine lozenge	otc	4	4	SUPPLYING
Menthol lozenge	otc	2	3	SUPPLYING
Menthol And Benzocaine And Dextromethorphan Hydrobromide lozenge	otc	2	2	SUPPLYING
Glycerin And Naphazoline Hydrochloride And Zinc Sulfate liquid	otc	1	2	SUPPLYING
Tetrahyrozoline Hydrochloride liquid	otc	2	2	SUPPLYING
Polyvinyl Alcohol And Povidone liquid	otc	2	2	SUPPLYING
Benzocaine lozenge	otc	2	2	SUPPLYING
Glycerin And Naphazoline Hydrochloride liquid	otc	1	1	SUPPLYING
Glycerin solution/ drops	otc	1	1	SUPPLYING
Cimetidine tablet	otc	1	1	SUPPLYING
Phenylephrine Hydrochloride And Glycerin solution/ drops	otc	1	1	SUPPLYING
Polyvinyl Alcohol And Povidone And Tetrahydrozoline Hydrochloride liquid	otc	1	1	SUPPLYING
Phenol And Glycerin spray	otc	1	1	SUPPLYING
Cromolyn Sodium spray, metered	otc	1	1	SUPPLYING
Hypromellose, Naphazoline Hydrochloride, Polysorbate 80 And Zinc Sulfate liquid	otc	1	1	SUPPLYING
Pectin And Menthol lozenge	otc	1	1	SUPPLYING
Acetaminophen And Diphenhydramine Hydrochloride powder, for solution	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.

+1 more

At a glance

TypeLabeler
Labeler codes52183, 67172
Filing names1
Drugs (active)20
Drugs (all time)20
US registrations42
Packages51

Recent events

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

Apr 25, 2014
RECALLRecall (Class III): PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 …
Apr 25, 2014
RECALLRecall (Class III): PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 …

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.