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 134 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	e07d880b-a12a-4e5e-94c0-bd36bcfe738c	2024-12-03	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	bd0a3679-1f7c-4c41-e053-2995a90a8fcb	2024-12-03	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	bd09e4f3-3211-8c08-e053-2a95a90a73f9	2024-12-03	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b373a3a8-68c4-0187-e053-2995a90aad62	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All In One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	a1b281ec-fd42-963c-e053-2a95a90a4b71	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	b3366ad4-5ef4-eb70-e053-2995a90acf33	2024-12-03	Warnings	Exact identifier application number: M012
Meijer Medicated Chest Rub, 3.53 oz. Lavender	MENTHOL, CAMPHOR, EUCALYPTUS OIL	Meijer Distribution	22516f25-b8aa-7511-e063-6394a90a6125	2024-12-03	Warnings	Exact identifier application number: M012
Tenalif Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cd9513-1a42-e990-e063-6294a90a57df	2024-12-03	Warnings	Exact identifier application number: M012
Tenalif Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cd94e7-1808-3bb3-e063-6294a90a4140	2024-12-03	Warnings	Exact identifier application number: M012
Nasal Decongestant PE and Pain Relief Plus Mucus Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Winco Foods, LLC	31531f90-8933-46ab-b722-cb63e7738639	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WINCO FOODS, LLC	f45f3ab4-5e10-3004-e053-2a95a90a0cb4	2024-12-03	Warnings	Exact identifier application number: M012
good sense allergy	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	2861b801-e778-822d-e063-6394a90aa1a8	2024-12-03	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	fe0cf681-f42c-430c-8429-f7ba4bc5a976	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Multisymptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5a5aa2ee-51b7-4698-bb27-3fb9d01bbea5	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	0ea270b7-9c28-49fb-9615-c4afdbdbc8f1	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	0955d856-cc4e-4ef2-8bc0-1a632a5b5f79	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	40c9c90d-6c9e-40d0-921d-1fd34eff90bb	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	3d068d30-9a00-49d7-bbe9-d6b53c19e86d	2024-12-02	Warnings	Exact identifier application number: M012
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	76724432-ff3c-404f-ba1f-5af68e3ab8c4	2024-12-02	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	73d4fc82-8508-44f8-83ca-9f32c5cd847b	2024-12-02	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