Home NDC 36800-788 topcare tussin dm max
Product NDC 36800-788
11-digit product format 368000788
Labeler code 36800
Product ID 36800-788_cbbc011d-affa-4a54-876d-c77175eca749
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan hydrobromide, Doxylamine succinate
Dosage form SOLUTION
Route ORAL
Labeler Topco Associates LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-02
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 30; 12.5 mg/20mL; mg/20mL
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 topcare tussin dm max
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 30 mg/20mL DOXYLAMINE SUCCINATE 12.5 mg/20mL
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 V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1115329 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 36800-788-26 topcare tussin dm max 118 mL in 1 BOTTLE SOLUTION 118 4 36800-788-26 topcare tussin dm max 1 in 1 CARTON SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-788 TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241113_e1118592-30ac-4505-9f38-c6d395c4cf5b.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 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-788-26 36800078826 1 BOTTLE in 1 CARTON (36800-788-26) / 118 mL in 1 BOTTLE 1 bottle 2019-05-02 0000-00-00 No No Current