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		2026-10-12

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 8 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus PE Head Congestion and Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Better Living Brands, LLC	28a4ec37-11dd-4134-81aa-851f081bf088	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health No Drip	NASAL MIST	CVS PHARMACY,INC.	60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa	2026-08-17	Warnings	Exact identifier application number: M012
Daytime Cold and Cough and NightTime Cold and Congestion Childrens	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreens	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2026-08-17	Warnings	Exact identifier application number: M012
CVS Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	CVS HEALTH	f01ab8ef-d29a-4e33-8a14-4c57ccdcc0d6	2026-08-17	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	KROGER COMPANY	30d50bbe-0a14-c985-e063-6294a90a47b3	2026-08-16	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	77f87e19-a9d5-479d-9434-bbde13210bfb	2026-08-15	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. DBA Leader	b1c2055b-4b5a-4fa2-b600-8930c9c8524c	2026-08-15	Warnings	Exact identifier application number: M012
Nighttime HBP Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY	146c9a62-0418-4b5d-9074-5be8a05f3f93	2026-08-15	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	610accad-2f8b-4605-9357-a58e6e18d417	2026-08-15	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength, Non-Drowsy	PSEUDOEPHEDRINE HCL	Amerisource Bergen	1fdb1ba5-4072-4baf-9e30-f01d57bf6d82	2026-08-15	Warnings	Exact identifier application number: M012
Cold and Flu Night	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	32c67914-d7cf-40ee-8682-0ba8ed691287	2026-08-15	Warnings	Exact identifier application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY	27820bce-6638-4f17-ac66-62b02b76bec3	2026-08-14	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE	CVS PHARMACY, INC.	004e104b-d6ff-48d5-8685-cd1bff45399a	2026-08-14	Warnings	Exact identifier application number: M012
CHILDRENS DIMETAPP COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	7babf4f6-ca0a-44a7-b1ea-d60e20d36f15	2026-08-14	Warnings	Exact identifier application number: M012
Nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	e7c8ffed-83b8-4088-b72c-d937e93f8b54	2026-08-14	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM and Overnight Cold and Flu	DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL	CVS	75520b77-d40b-4f43-b92a-7a3eba5b493f	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	bb24c298-1d00-4378-8de3-b4056220fa75	2026-08-14	Warnings	Exact identifier application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS Pharmacy,Inc.	6cb1d08b-e544-4084-b9ed-1e0d99a709c8	2026-08-14	Warnings, Adverse reactions	Exact identifier application number: M012
Theraflu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	932a3d40-9b52-4e91-bc61-6fd506f2d9e6	2026-08-14	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy,Inc.	91063edd-1e7e-41e9-8412-b14ef3749018	2026-08-14	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