Home NDC 0031-8692 Childrens Robitussin Nighttime Cough Long-Acting DM
Product NDC 0031-8692
11-digit product format 000318692
Labeler code 0031
Product ID 0031-8692_13dfb324-3f9f-0869-e063-6294a90a0770
Type HUMAN OTC DRUG
Nonproprietary name chlorpheniramine maleate, dextromethorphan hydrobromide
Dosage form SOLUTION
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-07-01
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 Nighttime Cough Long-Acting DM
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 0031-8692-13 Childrens Robitussin Nighttime Cough Long-Acting DM 118 mL in 1 BOTTLE SOLUTION 118 10 0031-8692-13 Childrens Robitussin Nighttime Cough Long-Acting DM 1 in 1 CARTON SOLUTION 1 10 0031-8692-13 RobitussinDay and Night Cough Relief Value Pack 118 mL in 1 BOTTLE SOLUTION 118 mL 15 mg in 10mL 1 0031-8692-13 RobitussinDay and Night Cough Relief Value Pack 1 in 1 CARTON SOLUTION 2 mg in 10mL 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-8692 CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [HALEON US HOLDINGS LLC] 10 Current NDC, Legacy NDC, 2 package rows 20240318_8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c.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 0031-8692-13 00031869213 1 BOTTLE in 1 CARTON (0031-8692-13) / 118 mL in 1 BOTTLE 1 bottle 2014-07-01 0000-00-00 No No Current