DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC

Product NDC: 54305-323
11-digit product format: 543050323
Labeler code: 54305
Product ID: 54305-323_d3750106-10cc-466e-a3cd-87ccfe381fe6
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 HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
Listing expiration: 2026-12-31

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
a535717d-ba55-45e9-9fc3-711b5d7dbf57	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
54305-323-19	2020-02-10	DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
54305-323-26	2020-02-10	DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
54305-323-19	2020-01-31	DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
54305-323-26	2020-01-31	DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54305-323-19	DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC	19 in 1 BAG	LOZENGE	19	5
54305-323-26	DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC	26 in 1 BAG	LOZENGE	26	5
54305-323-75	DUAL ACTION HONEY LEMON 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 HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DUAL ACTION HONEY LEMON 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
54305-323	DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]	5	Current NDC, Legacy NDC, 3 package rows	20241207_a535717d-ba55-45e9-9fc3-711b5d7dbf57.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 43 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	e9a53a2c-c5e8-48ba-97d9-c1e3cbd8da4b	2026-03-24	Warnings	Exact identifier application number: M012
Mucus Relief Congestion and Headache Maximum Strength	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	2638b541-e680-4949-a7c7-fcee165cbc92	2026-03-23	Warnings	Exact identifier application number: M012
Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	778dc0fb-30c3-4fbf-856a-7bca28181b39	2026-03-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS Pharmacy	eafd9823-c0ad-454a-b725-562d88ebec92	2026-03-23	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Grocery Outlet, Inc.	4db0470b-1bf0-9137-e063-6394a90a1d54	2026-03-23	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Grocery Outlet, Inc.	4db066d4-ddbe-ddce-e063-6394a90ac5f8	2026-03-23	Warnings	Exact identifier application number: M012
Throat Comfort Orange Mint Cinnamon Drops	MENTHOL	Ricola Ag	27487e5c-044c-41eb-865f-2f34351afd52	2026-03-23	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	f288eeca-9803-4962-a802-fe34f5983c7a	2026-03-23	Warnings	Exact identifier application number: M012
Throat Comfort Lemon Mint Ginger Drops	MENTHOL	Ricola Ag	d63b4d24-e926-418c-bb17-420aeaad5a62	2026-03-23	Warnings	Exact identifier application number: M012
Mucus Relief Congestion Cough Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	6e7dfee1-3de9-46c8-9b58-83fcf8ee72e0	2026-03-23	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	Hyvee Inc	44eafc83-8e7b-89b8-e063-6394a90ab0bc	2026-03-23	Warnings	Exact identifier application number: M012
Throat Comfort Lemon Mint Ginger Drops	MENTHOL	Ricola USA Inc.	5d7889b1-3866-49b0-97e1-1e883a52d3cb	2026-03-23	Warnings	Exact identifier application number: M012
Throat Comfort Orange Mint Cinnamon Drops	MENTHOL	Ricola USA Inc.	1487652c-dbc1-40f4-9d59-891ec74cc363	2026-03-23	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4e2a8b53-0074-42fd-8357-a39cc6afe608	2026-03-23	Warnings	Exact identifier application number: M012
Mucus Relief Severe Cold Daytime Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET Corporation	5ccaf3b0-096a-4644-9c6e-9f251c167b3c	2026-03-23	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	Grocery Outlet, Inc.	4d88180f-610c-d9ab-e063-6394a90a09f0	2026-03-21	Warnings	Exact identifier application number: M012
Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	HyVee Inc	cc371bc3-ba7a-430d-9ee4-22e9c50935f1	2026-03-20	Warnings	Exact identifier application number: M012
Daytime Nighttime Multi Symptom Cold Childrens	DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreens	da4c36f5-ec79-4489-bb18-8ddab79c34bd	2026-03-20	Warnings	Exact identifier application number: M012
Sanatos Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Pharmadel LLC	3bddcd5a-7776-49ff-e063-6294a90a5dd1	2026-03-20	Warnings	Exact identifier application number: M012
Vaporizing	CAMPHOR	Amazon.com Services LLC	21cfe9cb-5ff5-4331-8358-4d1d9646d6ac	2026-03-19	Warnings, Adverse reactions	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	a535717d-ba55-45e9-9fc3-711b5d7dbf57	5
1424614	menthol 8.3 MG Oral Lozenge	SCD	a535717d-ba55-45e9-9fc3-711b5d7dbf57	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54305-323-19	54305032319	19 LOZENGE in 1 BAG (54305-323-19)	19 lozenge	2011-04-03	0000-00-00	No	No	Current
54305-323-26	54305032326	26 LOZENGE in 1 BAG (54305-323-26)	26 lozenge	2011-04-03	0000-00-00	No	No	Current
54305-323-75	54305032375	175 LOZENGE in 1 BAG (54305-323-75)	175 lozenge	2020-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC	Ricola Ag	2024-12-05	HUMAN OTC DRUG LABEL	5