Home NDC 0031-9306 Robitussin Medi-Soothers
Product NDC 0031-9306
11-digit product format 000319306
Labeler code 0031
Product ID 0031-9306_14035c9f-dd1f-addd-e063-6294a90ab5dc
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 0031-9306-01 Robitussin Medi-Soothers 8 in 1 BLISTER PACK LOZENGE 8 2 0031-9306-02 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 0031-9306 ROBITUSSIN MEDI-SOOTHERS (DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL) LOZENGE [HALEON US HOLDINGS LLC] 2 Current NDC, 2 package rows 20240321_6bec225e-a203-4866-b0db-b76f73a6ae25.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 130 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kroger Daytime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE The Kroger Company e428dd83-c538-2a92-e053-2a95a90a0e16 2024-12-13 Warnings Exact identifier application number: M012 Kroger Nighttime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE The Kroger Company e46291c7-6f4d-46a2-e053-2a95a90a80a1 2024-12-13 Warnings Exact identifier application number: M012 Foster and Thrive Childrens Allergy Relief DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 7eaba464-5cdb-4bd4-b272-38fa108658d5 2024-12-13 Warnings Exact identifier application number: M012 SUDAFED OM Sinus Severe Original OXYMETAZOLINE HYDROCHLORIDE Kenvue Brands LLC 1d089074-3969-ce6e-e063-6294a90aa70c 2024-12-12 Warnings Exact identifier application number: M012 RIGHT REMEDIES Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc b4fc014c-7c5f-46a4-bf13-57103b6fa018 2024-12-11 Warnings Exact identifier application number: M012 Diphenhydramine Hydrochloride 25mg DIPHENHYDRAMINE HYDROCHLORIDE 25MG Strive Pharmaceuticals Inc b440eb2e-4de9-2b65-e053-2995a90abda8 2024-12-11 Warnings Exact identifier application number: M012 Meijer Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE Meijer Distribution Inc. 6933ca9d-a32d-d856-e053-2a91aa0a408e 2024-12-10 Warnings Exact identifier application number: M012 Effervescent Orange Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE Meijer Distribution Inc. 826b5c0d-7a75-bbf0-e053-2a91aa0aebd6 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 09141018-37ba-4c93-9051-1ed129c448c1 2024-12-10 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola USA Inc. 6ac9d95b-f6b9-4515-b126-697f8f839612 2024-12-10 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola USA Inc. 989d1529-2875-47bf-81df-65494d62be7a 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 82813342-2be2-4731-ae90-dbd5eed667a9 2024-12-10 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. b640a5d2-a7fe-486d-a65f-e7c993f950d6 2024-12-10 Warnings Exact identifier application number: M012 Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL Ricola USA Inc. c3f3c062-55e5-43c1-a016-ee47a7b388a5 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola USA Inc. ee4733b5-6e5a-438a-97da-110f3ef6c809 2024-12-10 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola USA Inc. f62fcc38-2d43-40b3-841f-c8eea9ebd1e1 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 8a6db093-7e52-443f-8dd6-94867606fef8 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola USA Inc. 5885343e-4a6e-44f7-87a4-d52599156197 2024-12-10 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola USA Inc. 0baf383c-886d-47ca-8a6d-221298c79446 2024-12-10 Warnings Exact identifier application number: M012 Tussin Multi Symptom Cold CF DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE Best Choice (Valu Merchandisers Company) 539b8972-2a46-468e-ad27-6672d746feb7 2024-12-10 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0031-9306-01 00031930601 8 LOZENGE in 1 BLISTER PACK (0031-9306-01) 8 lozenge 2023-06-01 No No Current 0031-9306-02 00031930602 16 LOZENGE in 1 BLISTER PACK (0031-9306-02) 16 lozenge 2023-06-01 No No Current