Home NDC 0031-2103 Robitussin
Product NDC 0031-2103
11-digit product format 000312103
Labeler code 0031
Product ID 0031-2103_430487ce-fbd6-66fc-e063-6294a90a32bf
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide, guaifenesin, doxylamine succinate
Dosage form KIT
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-01
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 Robitussin
Brand name suffix Day and Night Maximum Strength Cough DM
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020138 Internal RxNorm lookup 1115329 Internal RxNorm lookup 2056073 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 0031-2103-01 RobitussinDay and Night Maximum Strength Cough DM 1 in 1 CARTON KIT 1 1 0031-8718-13 RobitussinDay and Night Maximum Strength Cough DM 1 in 1 CARTON SOLUTION 12.5 mg in 20mL 1 0031-8718-13 RobitussinDay and Night Maximum Strength Cough DM 118 mL in 1 BOTTLE SOLUTION 118 mL 30 mg in 20mL 1 0031-8739-12 RobitussinDay and Night Maximum Strength Cough DM 118 mL in 1 BOTTLE SOLUTION 118 mL 20 mg in 20mL 1 0031-8739-12 RobitussinDay and Night Maximum Strength Cough DM 1 in 1 CARTON SOLUTION 400 mg in 20mL 1
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 Sample Exclude flag Status 0031-2103-01 00031210301 1 KIT in 1 CARTON (0031-2103-01) * 1 BOTTLE in 1 CARTON (0031-8739-12) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0031-8718-13) / 118 mL in 1 BOTTLE 1 kit 2021-03-01 No No Current 0031-8718-13 00031871813 1 in 1 CARTON Historical 0031-8739-12 00031873912 118 mL in 1 BOTTLE 118 ml Historical