Home NDC 71598-200 BupropiDex
Product NDC 71598-200
11-digit product format 715980200
Labeler code 71598
Product ID 71598-200_4081a7ee-5e35-6ad6-e063-6394a90a7047
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE
Dosage form TABLET
Route ORAL
Labeler DXM Pharmacuetical, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-01
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 BupropiDex
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 2173733 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 71598-200-15 BupropiDex 200 in 1 BOTTLE TABLET 200 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71598-200 BUPROPIDEX (DEXTROMETHORPHAN HYDROBROMIDE) TABLET [DXM PHARMACUETICAL, INC.] 2 Current NDC, 1 package rows 20241009_90cc9bcd-7891-4324-a1f4-f6df7a0457e0.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 78 of 79 · 1,576 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 71598-200-15 71598020015 200 TABLET in 1 BOTTLE (71598-200-15) 200 tablet 2023-12-01 No No Current