DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC

Product NDC: 54305-313
11-digit product format: 543050313
Labeler code: 54305
Product ID: 54305-313_298e8140-8f87-43fc-a9f8-87cd39cbfda6
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: 8.3 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	8.3 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
1424614	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
71ca8af7-172d-40da-be1e-ff3ab5568e74	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54305-313-19	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	19 in 1 BAG	LOZENGE	19	5
54305-313-26	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	26 in 1 BAG	LOZENGE	26	5
54305-313-75	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	175 in 1 BAG	LOZENGE	175	5

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]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	1
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54305-313	DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	5	Current NDC, Legacy NDC, 3 package rows	20241207_71ca8af7-172d-40da-be1e-ff3ab5568e74.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 136 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SanaTos Boost	DEXTROMETHORPHAN HBR	Pharmadel LLC	ae6a424f-f3f0-3f6c-e053-2995a90a972d	2024-11-18	Warnings	Exact identifier application number: M012
SanaTos Turbo Max Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Pharmadel LLC	d56a071c-a747-5397-e053-2995a90aad8b	2024-11-18	Warnings	Exact identifier application number: M012
equaline childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	a24021a0-ef68-4bce-ba53-d262d1025cc0	2024-11-17	Warnings	Exact identifier application number: M012
Cold and Cough DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	4d5f93c1-7752-4948-ba58-c4385cfc24c8	2024-11-17	Warnings	Exact identifier application number: M012
Good Sense Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L. Perrigo Company	8a87104f-94a4-4585-afd5-d610eea32e39	2024-11-17	Warnings	Exact identifier application number: M012
equate childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	c91e94f4-4c51-4fe7-ad2e-0b9dc58b51e4	2024-11-17	Warnings	Exact identifier application number: M012
foster and thrive childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strategic Sourcing Services LLC	1eac715b-351c-4b47-8d1d-6e921813c1a4	2024-11-15	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	298d2796-5ae5-4346-b6d2-2ced2dd29dc3	2024-11-15	Warnings	Exact identifier application number: M012
dg health day time severe cold and flu relief night time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Dolgencorp, LLC	f721b393-9ad5-4fc6-a2c5-bd89e58caf16	2024-11-15	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2	2024-11-15	Warnings	Exact identifier application number: M012
Rompe Pecho EX	GUAIFENESIN	Efficient Laboratories Inc	89ea23a5-0da7-407e-83d9-77a0b562f3af	2024-11-14	Warnings	Exact identifier application number: M012
basic care daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	ceb342da-ff6d-4c19-9f78-0033d028075e	2024-11-14	Warnings	Exact identifier application number: M012
Topcare Nite Time Day Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	efb8e0e2-0795-4f4a-8ca6-955f33bee143	2024-11-14	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal four	PHENYLEPHRINE HYDROCHLORIDE	Amerisource Bergen	a3d637dc-d957-458c-8a75-f948601a31aa	2024-11-14	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	ec8db98f-4fd1-4644-b76f-ff04f72e87f4	2024-11-13	Warnings	Exact identifier application number: M012
dg health tussin	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, LLC	6f9b8267-1e0b-430b-8e44-06408ae82ea4	2024-11-13	Warnings	Exact identifier application number: M012
Walgreens Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walgreens	b60e2cf9-11ec-469e-e053-2a95a90a712a	2024-11-13	Warnings	Exact identifier application number: M012
Kroger Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Kroger Company	69333774-3cf4-384d-e053-2a91aa0a48b3	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	H. E. Butt Grocery Company	6403fe3d-d82b-f4d5-e053-2991aa0ac7d6	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	Topco Associates LLC	a2929bcb-fa81-4f15-b087-a9996b5e7d1f	2024-11-13	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1424614	menthol 8.3 MG Oral Lozenge	PSN	71ca8af7-172d-40da-be1e-ff3ab5568e74	5
1424614	menthol 8.3 MG Oral Lozenge	SCD	71ca8af7-172d-40da-be1e-ff3ab5568e74	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54305-313-19	54305031319	19 LOZENGE in 1 BAG (54305-313-19)	19 lozenge	2011-04-03	0000-00-00	No	No	Current
54305-313-26	54305031326	26 LOZENGE in 1 BAG (54305-313-26)	26 lozenge	2011-04-03	0000-00-00	No	No	Current
54305-313-75	54305031375	175 LOZENGE in 1 BAG (54305-313-75)	175 lozenge	2011-04-03	0000-00-00	No	No	Current