DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC

Product NDC: 54305-331
11-digit product format: 543050331
Labeler code: 54305
Product ID: 54305-331_25d63830-f7f9-4e3a-a45f-0280a04d6d31
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: LOZENGE
Route: ORAL
Labeler: Ricola Ag
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-04-03
Substance: MENTHOL
Active strength: 8.5 mg/1
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: DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	8.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1232117	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
984c9793-163c-4b97-b244-9b471966a122	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54305-331-19	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	19 in 1 BAG	LOZENGE	19	8
54305-331-26	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	26 in 1 BAG	LOZENGE	26	8
54305-331-75	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	175 in 1 BAG	LOZENGE	175	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	4
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54305-331	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	8	Current NDC, Legacy NDC, 3 package rows	20241207_984c9793-163c-4b97-b244-9b471966a122.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 116 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nuvicare NightTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	37a88914-6234-4191-86f5-103c396c52af	2025-05-20	Warnings	Exact identifier application number: M012
Nuvicare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	NUVICARE LLC	1ea15426-4f3d-4a97-a590-6bd73bc6cbcd	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choice Nasal	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	3833e781-f6ee-4c6d-8756-d8ea2293a1f2	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choice Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	d45e99e5-ce66-4458-8d23-63a5dc7ae509	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choicel Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	460f0cc1-6a85-4d79-af87-a94fd151769e	2025-05-19	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	812a093f-cf83-4f7a-927a-1b5695be7f90	2025-05-19	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	SDA Laboratories, Inc.	1fd16b06-0c3e-4a30-ae6a-7b1632189c20	2025-05-16	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	Akron Pharma Inc.	79a6b8c7-0e81-4a46-a854-31f449042709	2025-05-16	Warnings	Exact identifier application number: M012
Tussin DM Sugar free	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AARNA USA, Inc.	3a521b65-fb35-4cc3-b826-88513afda0f9	2025-05-16	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	51c7628a-c7cf-498f-8fb1-db732e2b8b6e	2025-05-16	Warnings	Exact identifier application number: M012
BACTIMICINA CHILDRENS ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	DLC Laboratories, Inc.	eaf554d4-a758-4ed6-bec5-d6cbfedae408	2025-05-15	Warnings	Exact identifier application number: M012
Bactimicina Childrens Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	DLC Laboratories, Inc.	d407a583-07ae-4d47-b15a-24b5865c82da	2025-05-15	Warnings	Exact identifier application number: M012
Mucinex Nightshift Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	RB Health (US) LLC	35322238-d498-1a52-e063-6394a90ac9c4	2025-05-15	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	a1405038-80f2-45e5-bd8c-8c6b0ee348be	2025-05-15	Warnings	Exact identifier application number: M012
Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	b919f0fe-fae0-4bd8-9ccd-d7569b2a7070	2025-05-13	Warnings	Exact identifier application number: M012
Childrens Robitussin Honey Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	2025-05-13	Warnings	Exact identifier application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	77be57fb-0ae5-4fad-97f3-b6a4b57383a9	2025-05-13	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	c948e612-a491-4ad0-adb9-cf31ef76e4d8	2025-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	c3d0b70f-d213-4e38-88ab-1c89d93a391d	2025-05-10	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Safeway, Inc.	c639a36d-c683-4a4d-90b7-eadec7464aa2	2025-05-08	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1232117	menthol 8.5 MG Oral Lozenge	PSN	984c9793-163c-4b97-b244-9b471966a122	8
1232117	menthol 8.5 MG Oral Lozenge	SCD	984c9793-163c-4b97-b244-9b471966a122	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54305-331-19	54305033119	19 LOZENGE in 1 BAG (54305-331-19)	19 lozenge	2011-04-03	0000-00-00	No	No	Current
54305-331-26	54305033126	26 LOZENGE in 1 BAG (54305-331-26)	26 lozenge	2011-04-03	0000-00-00	No	No	Current
54305-331-75	54305033175	175 LOZENGE in 1 BAG (54305-331-75)	175 lozenge	2011-04-03	0000-00-00	No	No	Current