Home NDC 0031-8693 CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING
Product NDC 0031-8693
11-digit product format 000318693
Labeler code 0031
Product ID 0031-8693_1511b29b-fd49-44fd-aff1-89809fb6c971
Type HUMAN OTC DRUG
Nonproprietary name chlorpheniramine maleate, dextrometrorphan HBr
Dosage form LIQUID
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-01-01
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 2; 15 mg/10mL; mg/10mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 AND COLD LONG-ACTING
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 2 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 15 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup 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 1111440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0031-8693-12 CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING 1 in 1 CARTON LIQUID 1 6 0031-8693-12 CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING 118 mL in 1 BOTTLE LIQUID 118 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-8693 CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [HALEON US HOLDINGS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240316_becb4025-b63e-f2ea-9d11-d51fdf4e5c13.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 Units Marketing start Marketing end Sample Exclude flag Status 0031-8693-12 00031869312 1 BOTTLE in 1 CARTON (0031-8693-12) / 118 mL in 1 BOTTLE 1 bottle 2004-01-01 0000-00-00 No No Current