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: 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	63667-503	63667-503-04	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
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 160 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness Effervescent Cold Relief Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Family Dollar Services, Inc.	4e13511b-fbb5-2523-e054-00144ff88e88	2024-07-03	Warnings	Exact identifier application number: M012
Nighttime Cherry Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	TARGET CORPORATION	1c3f6cbf-a00d-45b9-e063-6394a90a797c	2024-07-02	Warnings	Exact identifier application number: M012
Cold Terminator Cold Relief	PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Wildman Business Group	e8538d9c-f9ba-40b1-b60f-f57921f39b64	2024-07-01	Warnings	Exact identifier application number: M012
Nighttime Severe Honey Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	1c02e465-8750-a088-e063-6394a90a8efb	2024-06-29	Warnings	Exact identifier application number: M012
ACTIDOM DMX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	0166322e-7dbb-4658-a5c5-1d0525bb7655	2024-06-28	Warnings	Exact identifier application number: M012
ACTINEL DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	ACTIPHARMA, LLC	16660d82-524b-42ca-8581-48237caa13b2	2024-06-28	Warnings	Exact identifier application number: M012
PurgenLabs Acetaminophen	ACTAMINOPHEN	Advanced Rx LLC	915c4608-af1b-4119-8291-4ce9fd701d76	2024-06-28	Warnings	Exact identifier application number: M012
Daytime Ultra Concentrated Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL	TARGET CORPORATION	1bc90b2f-612c-e977-e063-6294a90a40b4	2024-06-26	Warnings	Exact identifier application number: M012
Halls Mentholyptus	MENTHOL	Mondelez Global LLC	f5292c5b-5608-4e13-afc2-4f3d7133da88	2024-06-25	Warnings	Exact identifier application number: M012
Halls Strawberry	MENTHOL	Mondelez Global LLC	75638f29-7f2a-46b0-b8a0-e87bc7d6eba1	2024-06-25	Warnings	Exact identifier application number: M012
Good Sense Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	A-S Medication Solutions	5396a9cf-16eb-4628-9432-f49c67ffe2ce	2024-06-25	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	TARGET CORPORATION	130ca5f1-2951-ec6f-e063-6394a90a754f	2024-06-24	Warnings	Exact identifier application number: M012
Daytime and Nighttime Severe Honey Cold and Flu	DAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	TARGET CORPORATION	08fd1513-30ab-15da-e063-6394a90ab57d	2024-06-21	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe cold and flu	DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	0c0caa59-0637-bc33-e063-6294a90ae244	2024-06-21	Warnings	Exact identifier application number: M012
Halls Strawberry	MENTHOL	Mondelez Global LLC	de401eb4-3282-4298-8a51-15d268253464	2024-06-21	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreens	e4515d0e-c12b-40cd-8218-6d91476cfebd	2024-06-21	Warnings	Exact identifier application number: M012
SUDOGEST	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	1811199f-bf88-475f-8f94-b372db4bead3	2024-06-20	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Soft Chews	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	91dbb541-6a86-4803-a1fe-1bf61b457c34	2024-06-19	Warnings	Exact identifier application number: M012
Tukol Max Action Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	aedce1f9-4902-4c51-92e0-6056196394c2	2024-06-14	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	dbc71f58-0704-4d2b-aed1-0dc01f980006	2024-06-11	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