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		2026-10-21

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 119 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2	2025-02-19	Warnings	Exact identifier application number: M012
Coricidin HBP Cold and Flu	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	Bayer HealthCare LLC.	763a5334-a741-4678-9947-603776622450	2025-02-18	Warnings	Exact identifier application number: M012
Sof Skin Vaporizing Chest Rub and Cough Suppressant	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Viny Health and Beauty Inc	46ae16a4-b8a7-44de-ae1a-9bb503c15ea0	2025-02-18	Warnings	Exact identifier application number: M012
Pain Reliever PM	ACETAMINOPHEN DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	4897d1df-4fb3-46e2-bbf0-847e964dca0a	2025-02-18	Warnings	Exact identifier application number: M012
meijer EXTRA STRENGTH Pain Relief PM Caplet	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bee7e4f-1813-1bdf-e063-6294a90a6a32	2025-02-17	Warnings	Exact identifier application number: M012
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL	Kroger Company	a24f09d9-60f1-853a-e053-2a95a90ae1fa	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH COLD AND FLU	ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	FAMILY DOLLAR SERVICES	a7343bea-53cc-4621-e053-2a95a90a2a5f	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGHT DAY COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8ebccf-6813-2dca-e053-2a95a90a032b	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8f0465-1595-0b0f-e053-2a95a90a0081	2025-02-15	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	KROGER COMPANY	9bb7aaf0-6698-9a5c-e053-2a95a90a097c	2025-02-14	Warnings	Exact identifier application number: M012
Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H-E-B	db432947-fe02-79b2-e053-2a95a90af4a9	2025-02-14	Warnings	Exact identifier application number: M012
Halls Sugar Free Cherry	MENTHOL	Mondelez Global LLC	ea8dfe96-f6a4-4172-bf9e-ae3cf606ff50	2025-02-14	Warnings	Exact identifier application number: M012
Halls Sugar Free Watermelon	MENTHOL	Mondelez Global LLC	c4c090ca-f083-74e0-e053-2a95a90a9d60	2025-02-14	Warnings	Exact identifier application number: M012
Tukol Max Action	OXYMETAZOLINE HYDROCHLORIDE	Genomma Lab USA	73358103-43dc-4b11-9c89-9a6ba45bf1af	2025-02-14	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association Inc.	6c4e867b-24b9-4525-9fab-10f1e7910b13	2025-02-13	Warnings	Exact identifier application number: M012
DAYTIME- NIGHTTIME COLD AND FLU	DAYTIME NIGHTTIME COLD AND FLU	TARGET CORP	9def204a-ee1e-6868-e053-2995a90a76b8	2025-02-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu and Nigttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	f2c11b63-278f-64de-e053-2995a90a5aae	2025-02-12	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	BETTER LIVING BRANDS LLC.	f29c604a-271d-a702-e053-2a95a90a3427	2025-02-12	Warnings	Exact identifier application number: M012
Nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	f2c01090-645c-1efe-e053-2995a90a7df5	2025-02-12	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	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