Home NDC 69367-353 WesTussin DM NF
Product NDC 69367-353
11-digit product format 693670353
Labeler code 69367
Product ID 69367-353_820baecb-bfb9-411c-868f-670b81474059
Type HUMAN OTC DRUG
Nonproprietary name WesTussin DM NF
Dosage form LIQUID
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-19
Substance PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; DEXBROMPHENIRAMINE MALEATE
Active strength 7.5; 15; 2 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base WesTussin DM NF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 7.5 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL DEXBROMPHENIRAMINE MALEATE 2 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup 9D2RTI9KYH Internal UNII lookup BPA9UT29BS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1812101 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69367-353-16 WesTussin DM NF 473 mL in 1 BOTTLE LIQUID 473 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-353 WESTUSSIN DM NF LIQUID [WESTMINSTER PHARMACEUTICALS, LLC] 3 Current NDC, 1 package rows 20240810_4e0f9f97-a31c-41ac-9d6c-d81efd20fcef.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69367-353-16 69367035316 473 mL in 1 BOTTLE (69367-353-16) 473 ml 2023-07-19 No No Current