EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT

Product NDC: 63667-503
11-digit product format: 636670503
Labeler code: 63667
Product ID: 63667-503_ebff7e9e-acbb-4ce0-bc94-1d85221d45a5
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: LOZENGE
Route: ORAL
Labeler: Ricola USA Inc.
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: 2026-12-31
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	63667-503	63667-503-04	D	Discontinued by firm		2026-10-20

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: 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
0baf383c-886d-47ca-8a6d-221298c79446	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63667-503-04	2020-02-10	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
63667-503-19	2020-02-10	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
63667-503-26	2020-02-10	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
63667-503-04	2020-01-31	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
63667-503-19	2020-01-31	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
63667-503-26	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
63667-503-04	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	4 in 1 PACKAGE	LOZENGE	4	6
63667-503-19	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	19 in 1 BAG	LOZENGE	19	6
63667-503-26	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	26 in 1 BAG	LOZENGE	26	6

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 USA INC.]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]	2
INVERT SUGAR	INACTIVE INGREDIENT	ED959S6ACY	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]	2
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63667-503	EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]	6	Current NDC, Legacy NDC, 3 package rows	20241211_0baf383c-886d-47ca-8a6d-221298c79446.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 81 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Basic Care Honey Lemon Cough Drops	MENTHOL	Amazon.com	c0937b13-f679-a764-e053-2a95a90abf89	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care SF Menthol Cough Drops	MENTHOL	Amazon.com	c0946295-7cf0-1bd8-e053-2a95a90af5af	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care SF Honey Lemon Cough Drops	MENTHOL	Amazon.com	cf82fb0b-1b4d-def1-e053-2995a90a6fd9	2025-12-05	Warnings	Exact identifier application number: M012
G-DOLOGEN	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Kramer Novis	7a4e1d64-2510-405f-a1dc-e02a803b6fbd	2025-12-05	Warnings	Exact identifier application number: M012
Quality Choice Severe Cold and Cough Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	Chain Drug Manufacturing Assn	ce658dd5-b683-436e-b16b-0c06f6f87fd9	2025-12-04	Warnings	Exact identifier application number: M012
Quality Choice Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	a87ba15f-b5a9-4983-a721-ca7f705aea86	2025-12-04	Warnings	Exact identifier application number: M012
Quality Choice	PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	a12e2e66-d2f3-47a6-a915-a309ae828d27	2025-12-04	Warnings	Exact identifier application number: M012
Childrens Mucus Relief Chest Congestion	GUAIFENESIN	Chain Drug Manufacturing Assn	034d39c0-9aad-4dff-a158-a041b9f0504f	2025-12-04	Warnings	Exact identifier application number: M012
Quality Choice	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	d01b8fb6-1ddf-4901-bda6-ae608e94a6a4	2025-12-04	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Chain Drug Manufacturing Assn	06822a28-3f82-471d-8db5-c5981b263a03	2025-12-04	Warnings	Exact identifier application number: M012
QUALITY CHOICE	PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	14596551-dd82-46b3-8eb8-e69efaea105b	2025-12-04	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Lil Drug Store Products	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	fd5c20ed-5520-4db0-bfd4-995f043af2a4	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Original	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	89c165ba-3ad5-49b5-a5bb-423dc8e15bad	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold Powerfast Fizz Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	a2b30c27-b836-f09f-e053-2995a90ac383	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	a37c9d9d-52db-23ff-e053-2995a90a8f76	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer Healthcare LLC.	dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	a68df74d-dd26-3ae9-e053-2995a90a08d6	2025-12-04	Warnings	Exact identifier application number: M012
Circle K Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	55662ada-677e-4048-9529-5bca44076316	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	b13d5132-cb91-3cf6-e053-2a95a90aa47c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	bd97e91f-1ae1-379c-e053-2995a90acfdd	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	0baf383c-886d-47ca-8a6d-221298c79446	6
1424614	menthol 8.3 MG Oral Lozenge	SCD	0baf383c-886d-47ca-8a6d-221298c79446	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63667-503-04	63667050304	4 in 1 PACKAGE						Historical
63667-503-19	63667050319	19 LOZENGE in 1 BAG (63667-503-19)	19 lozenge	2013-05-27	0000-00-00	No	No	Current
63667-503-26	63667050326	26 LOZENGE in 1 BAG (63667-503-26)	26 lozenge	2013-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT	Ricola USA Inc. \| Ricola Ag	2024-12-10	HUMAN OTC DRUG LABEL	6