Home NDC 73629-005 DEXTROMETHORPHAN HBR 15 MG
Product NDC 73629-005
11-digit product format 736290005
Labeler code 73629
Product ID 73629-005_2b3b3017-9dd9-a696-e063-6394a90a4835
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HBR 15 MG
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler AMZ789 LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-01
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 mg/1
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 DEXTROMETHORPHAN HBR 15 MG
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090487 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 73629-005-10 DEXTROMETHORPHAN HBR 15 MG 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73629-005 DEXTROMETHORPHAN HBR 15 MG CAPSULE, LIQUID FILLED [AMZ789 LLC] 2 Current NDC, Legacy NDC, 1 package rows 20250110_e2175017-6a0d-0155-e053-2995a90a65d6.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 98 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 73629-005-10 73629000510 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (73629-005-10) 2022-05-01 0000-00-00 No No Current