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 42 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CHAIN DRUG MARKETING ASSOCIATION INC	7d1b3418-85a8-4ca0-bca7-261b2b58032a	2026-03-26	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH COLD, FLU AND SORE THROAT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy, Inc.	bfc38500-5706-0d03-e053-2995a90a5c72	2026-03-26	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS HEALTH CORP	2baa0861-dbef-7910-e063-6394a90a117e	2026-03-26	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF	ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL	CVS Pharmacy, Inc.	c17d5ba7-3302-7931-e053-2a95a90a5a6c	2026-03-26	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy, Inc.	c17b8f17-95f6-37e4-e053-2995a90a411a	2026-03-26	Warnings	Exact identifier application number: M012
Ultra concentrated Daytime/ Nighttime Severe Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGEL	CVS PHARMACY, INC	24cedaec-06a6-8fde-e063-6394a90a3d7a	2026-03-26	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS HONEY SUGAR-FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	23079537-1c06-1373-e063-6394a90a37d2	2026-03-26	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS MENTHOL SUGAR-FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f2fa8c-071f-50ab-e063-6394a90a4a4a	2026-03-26	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	3618ccf0-1f30-42e0-bb50-bfa45cf2b583	2026-03-26	Warnings	Exact identifier application number: M012
Vicks childrens Cough Congestion Night	PHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	87231460-8b45-b995-e053-2a91aa0a6c43	2026-03-26	Warnings	Exact identifier application number: M012
VICKS CHILDRENS COUGH CONGESTION	DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	f1d67797-c806-261d-e053-2a95a90a3c15	2026-03-26	Warnings	Exact identifier application number: M012
childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	HyVee Inc	686f43ea-4296-4eee-b762-9a9e68344340	2026-03-26	Warnings	Exact identifier application number: M012
Tussin DM Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	59d3a486-97c2-4e60-90e2-1b5bfa7638c7	2026-03-26	Warnings	Exact identifier application number: M012
flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Meijer Distribution Inc	1a853e47-21a2-40e1-9e64-290af4843b13	2026-03-25	Warnings	Exact identifier application number: M012
cold flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	HyVee Inc	c4dcc427-aeec-4a26-80f3-02a4b227a520	2026-03-25	Warnings	Exact identifier application number: M012
Walgreens Lavender Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walgreen Company	327a1a00-852d-2756-e063-6394a90a5e29	2026-03-25	Warnings	Exact identifier application number: M012
Walgreens Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walgreen Company	2d56ddcd-3cc8-51eb-e063-6394a90ae745	2026-03-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TWIN MED LLC	7b000478-649d-4511-b3e0-eea6995b9784	2026-03-25	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS HONEY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f32457-23bf-d8a8-e063-6294a90a1e0d	2026-03-25	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS HONEY SUGAR-FREE	Medical Group Care LLC	f4a9ba87-c2a1-2de0-e053-2a95a90ada4c	2026-03-25	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