EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT

Product NDC: 54305-617
11-digit product format: 543050617
Labeler code: 54305
Product ID: 54305-617_431a93f6-3f9d-4f52-8706-9de6ac2d7d26
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: LOZENGE
Route: ORAL
Labeler: Ricola Ag
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-05-27
Substance: MENTHOL
Active strength: 8.3 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	54305-617	54305-617-04	D	Discontinued by firm		2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT
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
ea42e516-2ef8-41c9-ae4e-571f0147bc6b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
54305-617-04	2020-02-10	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
54305-617-19	2020-02-10	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
54305-617-26	2020-02-10	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
54305-617-04	2020-01-31	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
54305-617-19	2020-01-31	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
54305-617-26	2020-01-31	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54305-617-04	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	4 in 1 PACKAGE	LOZENGE	4	7
54305-617-19	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	19 in 1 BAG	LOZENGE	19	7
54305-617-26	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	26 in 1 BAG	LOZENGE	26	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA AG]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA AG]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA AG]	2
INVERT SUGAR	INACTIVE INGREDIENT	ED959S6ACY	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA AG]	2
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA AG]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA AG]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54305-617	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA AG]	7	Current NDC, Legacy NDC, 3 package rows	20241207_ea42e516-2ef8-41c9-ae4e-571f0147bc6b.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 58 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pocket Farmacy	MENTHOL	Saje Natural Business Inc.	bdc15c6f-73b4-488e-9134-e70565df71bb	2026-01-14	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCL 50 MG	DIPHENHYDRAMINE HCL	YYBA Corporation	4b012549-3958-43c1-9de7-897c5d8b20d3	2026-01-14	Warnings	Exact identifier application number: M012
Rite Aid Pharmacy congestion relief vaporizing steam	VAPORIZING STEAM	Rite Aid Pharmacy	0fb86b23-0313-8fd8-e063-6394a90a0f5f	2026-01-14	Warnings	Exact identifier application number: M012
Vapo Steam	VAPO STEAM	TOPCO ASSOCIATES, LLC	f216f69f-9580-25ac-e053-2995a90a5ac6	2026-01-14	Warnings	Exact identifier application number: M012
Leader Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Cardinal Health 110, LLC. dba Leader	f27bf0b2-25cc-474c-ab6b-f227ed3525fa	2026-01-14	Warnings	Exact identifier application number: M012
Sinus PE plus Allergy	CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	Walgreen Company	a15979d4-87bf-42e7-b1f2-783496072141	2026-01-13	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	41f4bf6d-f83c-92e4-e063-6394a90aebab	2026-01-13	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	3e608643-1a74-b474-e063-6294a90ad2e0	2026-01-13	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	462cbf3d-51b1-dab9-e063-6394a90a70ba	2026-01-13	Warnings	Exact identifier application number: M012
Pocket Farmacy	MENTHOL	Saje Natural Business Inc.	4260542e-0980-4b0b-8177-1c9f2c53b5a6	2026-01-13	Warnings	Exact identifier application number: M012
Sweet Comfort	MENTHOL	Saje Natural Business Inc.	cf13cccd-723d-4d61-8a5e-b36281605cc7	2026-01-13	Warnings	Exact identifier application number: M012
Fortify	MENTHOL	Saje Natural Business Inc.	0320a305-99d1-4909-94cc-cd6509ecb948	2026-01-13	Warnings	Exact identifier application number: M012
Rolling Farmacy	MENTHOL	Saje Natural Business Inc.	a38765a9-22cd-4fc5-b5ab-c3cacbd52c74	2026-01-13	Warnings	Exact identifier application number: M012
Home Farmacy	MENTHOL	Saje Natural Business Inc.	add35d10-b27a-4ae8-b2de-8a285aaef155	2026-01-13	Warnings	Exact identifier application number: M012
Traveling Farmacy	MENTHOL	Saje Natural Business Inc.	5b70f5aa-ed36-65ab-e053-2a91aa0a6777	2026-01-13	Warnings	Exact identifier application number: M012
sinus plus allergy PE maximum strength	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	660d3c80-f249-41dd-aa93-a0b1e635ead0	2026-01-13	Warnings	Exact identifier application number: M012
Chest Comfort	MENTHOL	Saje Natural Business Inc.	8a3db169-6dd7-4dfd-8360-90315288f21b	2026-01-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	H E B	c9e977b6-fba6-49ea-9d80-b43b0842bbe1	2026-01-12	Warnings	Exact identifier application number: M012
PE Sinus Congestion	PHENYLEPHRINE HCL	Topco Associates, LLC	3264e291-7a0f-4e25-8390-ba441f22f650	2026-01-12	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	3f44cff6-240a-4a8d-aaa1-0da75a31a47b	2026-01-12	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	ea42e516-2ef8-41c9-ae4e-571f0147bc6b	7
1424614	menthol 8.3 MG Oral Lozenge	SCD	ea42e516-2ef8-41c9-ae4e-571f0147bc6b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54305-617-04	54305061704	4 in 1 PACKAGE						Historical
54305-617-19	54305061719	19 LOZENGE in 1 BAG (54305-617-19)	19 lozenge	2013-05-27	0000-00-00	No	No	Current
54305-617-26	54305061726	26 LOZENGE in 1 BAG (54305-617-26)	26 lozenge	2013-05-27	0000-00-00	No	No	Current