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: 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
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 82 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Maximum Strength Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51dca689-e4a0-5526-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6f2d18f6-935f-9215-e053-2a91aa0aedd3	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6fb28fa1-ebbb-64bf-e053-2991aa0a1de4	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5213ca7f-5a78-6471-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6f7ba256-ed14-5fe0-e053-2a91aa0aacc1	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	6f7bf92d-4aaf-86e0-e053-2991aa0a2d91	2025-12-04	Warnings	Exact identifier application number: M012
Afrin NoDrip Allergy Sinus Night	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	b023a571-7e54-7c63-e053-2a95a90a0f78	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE	Bayer HealthCare LLC.	b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d	2025-12-04	Warnings	Exact identifier application number: M012
Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	e3231869-8ddf-9d17-e053-2995a90ae6d5	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Multi Symptom Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	ae7cf41e-b618-d6bb-e053-2a95a90a6692	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Allergy Sinus Nasal	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	c2d903bf-5c51-82d7-e053-2995a90aea49	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold, Cough and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	351d3c5c-05c8-921a-e063-6394a90abef9	2025-12-04	Warnings	Exact identifier application number: M012
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold Flu And Chest Congestion	ACETAMINOPHEN, GUAIFENESIN	Bayer HealthCare LLC.	de95d2dd-e766-f7ec-e053-2995a90afc5f	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold and Flu Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e4f3f906-2252-21d1-e053-2a95a90a85df	2025-12-04	Warnings	Exact identifier application number: M012
Afrin No Drip Pump Mist Bundle Pack	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	16c52c79-baec-87db-e063-6294a90a3b3b	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	0f5ec576-f788-40aa-9088-0dd672e3cc7c	2025-12-04	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	432a79a9-c69d-4514-894a-7832e1b745ef	2025-12-04	Warnings	Exact identifier application number: M012
GENCONTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	69d16d25-b09b-430e-8e01-0962d840dc21	2025-12-04	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	H E B	7c04ab14-af28-4598-90ef-56ac11902c7d	2025-12-04	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	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