Home NDC 0031-8694 Childrens Robitussin Cough Long-Acting
Product NDC 0031-8694
11-digit product format 000318694
Labeler code 0031
Product ID 0031-8694_13de389a-3701-8e4c-e063-6294a90a2587
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide
Dosage form LIQUID
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-01-01
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 7.5 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 Childrens Robitussin Cough Long-Acting
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 7.5 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 1370211 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 0031-8694-12 Childrens Robitussin Cough Long-Acting 1 in 1 CARTON LIQUID 1 10 0031-8694-12 Childrens Robitussin Cough Long-Acting 118 mL in 1 BOTTLE LIQUID 118 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-8694 CHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HALEON US HOLDINGS LLC] 10 Current NDC, Legacy NDC, 2 package rows 20240318_75bc7827-4439-e6a8-a65c-7154d5592e58.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 0031-8694-12 00031869412 1 BOTTLE in 1 CARTON (0031-8694-12) / 118 mL in 1 BOTTLE 1 bottle 2015-07-01 0000-00-00 No No Current