Labeler · US market

Kramer Novis

Kramer Novis is a US drug labeler with US FDA registrations covering 18 drug concepts (18 currently active) across 32 packages. It is currently the only active US supplier of 10 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes52083

Active drugs18

Registrations26 active / 26

Packages32

Sole supplier of10 drugs

Portfolio18 drugs · US

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

Drug	Type	NDCs	Packages	Status
Dextromethorphan Hbr And Guaifenesin syrup	otc	2	4	SUPPLYING
Dextromethorphan, Guaifenesin, And Phenylephrine syrup	otc	2	4	SUPPLYING
Dextromethorphan Hydrobromide, Brompheniramine Maleate, Phenylephrine Hydrochloride syrup	otc	2	4	SUPPLYING
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride syrup	otc	3	3	SUPPLYING
Acetaminophen, Dexbrompheniramine Maleate tablet	otc	2	2	SUPPLYING
Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide syrup	otc	2	2	SUPPLYING
Guaifenesin, Phenylephrine Hcl,dextromethorphan Hydrobromide syrup	otc	2	2	SUPPLYING
Dextromethorphan Hydrobromide, Glycerol Guaiacolate syrup	otc	1	1	SUPPLYING
Dexbromopheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl syrup	otc	1	1	SUPPLYING
Guiafenesin, Phenylephrine Hcl solution/ drops	otc	1	1	SUPPLYING
Zinc Oxide cream	otc	1	1	SUPPLYING
Benzocaine, Zinc Chloride spray	otc	1	1	SUPPLYING
Dextromethorphan Hbr, Guaifenesin solution	otc	1	1	SUPPLYING
Undecylenic Acid liquid	otc	1	1	SUPPLYING
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl solution	otc	1	1	SUPPLYING
Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride solution	otc	1	1	SUPPLYING
Dextromethorphan Hbr, Guiafenesin, Phenylephrine Hcl solution/ drops	otc	1	1	SUPPLYING
Dextromethorphan Hydrobromide, Guaifenesin syrup	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 codes52083
Filing names1
Drugs (active)18
Drugs (all time)18
US registrations26
Packages32

Recent events

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

Apr 20, 2023
RECALLRecall (Class I): G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal…
Jun 21, 2019
RECALLRecall (Class II): GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cher…
Jun 21, 2019
RECALLRecall (Class II): SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE …
May 28, 2019
RECALLRecall (Class I): Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free…

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.