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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6bec225e-a203-4866-b0db-b76f73a6ae25	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

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 118 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HISTEX-DM New Formulation	DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI	Allegis Pharmaceuticals, LLC	30010401-e5b4-2bd9-e063-6394a90a0b0b	2025-03-10	Warnings	Exact identifier application number: M012
daytime severe cold multi-symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd	2025-03-08	Warnings	Exact identifier application number: M012
Cold and Head Congestion Relief Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	a39778ba-1f63-4495-8e9b-44b0bdd7f71a	2025-03-08	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat Day	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	2e9540e4-bd1d-9370-e063-6294a90affcb	2025-03-07	Warnings	Exact identifier application number: M012
Herbal Cough Drops Original Herb	COUGH DROPS	Topco Associates LLC	2fb22181-aee3-d0bf-e063-6294a90a7865	2025-03-06	Warnings	Exact identifier application number: M012
REVASOL DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Rnv LLC	2f9ddcc3-b913-f8b0-e063-6294a90a93ab	2025-03-05	Warnings	Exact identifier application number: M012
Herbal Throat Drops Lemon Mint Herb	THROAT DROPS	Topco Associates LLC	2fa086b4-3b0e-0df8-e063-6294a90a6769	2025-03-05	Warnings	Exact identifier application number: M012
Redicare Nasal and Sinus Decongestant	REDICARE NASAL AND SINUS DECONGESTANT	Redicare LLC	2f24be68-f30e-d916-e063-6294a90a7e31	2025-03-04	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HCL ORAL SOLUTION	Kesin Pharma Corporation	2f871005-de4d-8b2a-e063-6394a90aa43a	2025-03-04	Warnings	Exact identifier application number: M012
CVS Daytime Cough Relief Chews - Citrus Punch	DEXTROMETHORPHAN HBR	CVS	2f885f1b-7ff5-251b-e063-6394a90a656f	2025-03-04	Warnings	Exact identifier application number: M012
CVS Dex-Dox Kids Nighttime Cough Suppressant	DEXTROMETHORPHAN HBR	CVS	2f8b6f5e-399c-b033-e063-6294a90ac3d1	2025-03-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ff8b096c-8f01-4a8c-a98f-e4aa4d688e95	2025-03-04	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	7-ELEVEN	2f3c43dd-175f-722e-e063-6294a90acff9	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	7-ELEVEN	2f3c3c65-4178-6304-e063-6294a90a51fa	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efbffd7-bbdd-c5f5-e063-6294a90a15f0	2025-02-25	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efc46c9-a421-1998-e063-6394a90aeb64	2025-02-25	Warnings	Exact identifier application number: M012
Redicare Cough Drops Cherry Flavored	CHERRY FLAVORED MENTHOL COUGH DROPS	Redicare LLC	2efeaafa-ee96-37ee-e063-6394a90a9a4b	2025-02-25	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Genexa Inc.	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2025-02-20	Warnings	Exact identifier application number: M012
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	596ec923-56a0-4b6e-a69c-8d740feb75a2	2025-02-20	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	77a2dc96-73ee-4ca2-b1fe-406995802606	2025-02-19	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1301246	dextromethorphan HBr 5 MG / menthol 5 MG Oral Lozenge	PSN	6bec225e-a203-4866-b0db-b76f73a6ae25	2
1301246	dextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge	SCD	6bec225e-a203-4866-b0db-b76f73a6ae25	2

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