Home NDC 0031-9310 ROBITUSSIN LONG-ACTING COUGH Soft CHEWS
Product NDC 0031-9310
11-digit product format 000319310
Labeler code 0031
Product ID 0031-9310_4471f0f1-079c-219b-e063-6294a90ae0bb
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-19
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 mg/1
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 ROBITUSSIN LONG-ACTING COUGH Soft CHEWS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
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 2173731 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 0031-9310-10 ROBITUSSIN LONG-ACTING COUGH Soft CHEWS 10 in 1 BOTTLE TABLET, CHEWABLE 10 3 0031-9310-20 ROBITUSSIN LONG-ACTING COUGH Soft CHEWS 20 in 1 BOTTLE TABLET, CHEWABLE 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-9310 ROBITUSSIN LONG-ACTING COUGH SOFT CHEWS (DEXTROMETHORPHAN HYDROBROMIDE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC] 2 Current NDC, 2 package rows 20240619_f22248b7-7abd-4df7-a986-dae357ebe8f1.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 Marketing start Sample Exclude flag Status 0031-9310-10 00031931010 10 TABLET, CHEWABLE in 1 BOTTLE (0031-9310-10) 2024-06-19 No No Current 0031-9310-20 00031931020 20 TABLET, CHEWABLE in 1 BOTTLE (0031-9310-20) 2024-06-19 No No Current