Home NDC 0031-9307 Robitussin Medi-Soothers
Product NDC 0031-9307
11-digit product format 000319307
Labeler code 0031
Product ID 0031-9307_1571df1a-4352-e93d-e063-6294a90a576a
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide, menthol
Dosage form LOZENGE
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL, UNSPECIFIED FORM
Active strength 5; 5 mg/1; 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 Medi-Soothers
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 mg/1 MENTHOL, UNSPECIFIED FORM 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1301246 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 0031-9307-01 Robitussin Medi-Soothers 16 in 1 BLISTER PACK LOZENGE 16 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-9307 ROBITUSSIN MEDI-SOOTHERS (DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL) LOZENGE [HALEON US HOLDINGS LLC] 2 Current NDC, 1 package rows 20240408_4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5.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 123 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 0031-9307-01 00031930701 16 LOZENGE in 1 BLISTER PACK (0031-9307-01) 16 lozenge 2023-06-01 No No Current