Home NDC 69367-398 Pyrilamine Maleate and Dextromethorphan Hydrobromide
Product NDC 69367-398
11-digit product format 693670398
Labeler code 69367
Product ID 69367-398_c0f27c81-43c1-4e63-b3a4-ccbd15f35ab4
Type HUMAN OTC DRUG
Nonproprietary name Pyrilamine Maleate and Dextromethorphan Hydrobromide
Dosage form LIQUID
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-15
Substance DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE
Active strength 7.5; 7.5 mg/5mL; mg/5mL
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Pyrilamine Maleate and Dextromethorphan Hydrobromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5mL PYRILAMINE MALEATE 7.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup R35D29L3ZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1423307 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69367-398-16 Pyrilamine Maleate and Dextromethorphan Hydrobromide 473 mL in 1 BOTTLE LIQUID 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-398 PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [WESTMINSTER PHARMACEUTICALS, LLC] 2 Current NDC, 1 package rows 20240829_dd068449-9d24-41e6-8a6e-f69c9fe263f2.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 153 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 69367-398-16 69367039816 473 mL in 1 BOTTLE (69367-398-16) 473 ml 2024-07-15 No No Current