Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217338
Company: RB HLTH

Products on NDA 217338

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM	30MG;600MG;110MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217338

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2025	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217338Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217338Orig1s000ltr.pdf

Labels for NDA 217338

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217338Orig1s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.