Home NDC 36800-509 Cough Relief
Product NDC 36800-509
11-digit product format 368000509
Labeler code 36800
Product ID 36800-509_931fb6be-5864-4a3e-b62a-5566990fa0cc
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr
Dosage form LIQUID
Route ORAL
Labeler TOP CARE (Topco Associates LLC)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-03-31
Marketing end 2026-11-28
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 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
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 Cough Relief
Brand name suffix Adult Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL
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 1090496 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 36800-509-04 Cough ReliefAdult 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 8 36800-509-04 Cough ReliefAdult 1 in 1 BOX LIQUID 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-509 COUGH RELIEF ADULT (DEXTROMETHORPHAN HBR) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 7 Current NDC, Legacy NDC, 2 package rows 20240616_b2ebfeb3-e248-40bf-81d3-81c5fb532dbe.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 Marketing start Marketing end Sample Exclude flag Status 36800-509-04 36800050904 1 BOTTLE, PLASTIC in 1 BOX (36800-509-04) / 118 mL in 1 BOTTLE, PLASTIC 2016-03-31 2026-11-28 No No Current