Major Extra Strength Cold and Hot Pain Relief Therapy

Product NDC: 0904-5694
11-digit product format: 009045694
Labeler code: 0904
Product ID: 0904-5694_5f8d597b-7afa-1c26-e053-2991aa0a6bc1
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: PATCH
Route: TOPICAL
Labeler: Major Pharmaceuticals
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-06-30
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 750 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-5694		D	Discontinued by firm		2026-10-05
excluded package	package	0904-5694	0904-5694-01	D	Discontinued by firm		2026-10-05

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-5694-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-5694-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-5694-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-5694-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-5694-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-5694-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-5694-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-5694-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-5694-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-5694-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-5694-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-5694-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0904-5694-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0904-5694-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0904-5694-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0904-5694-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0904-5694-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0904-5694-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0904-5694-01	2024-11-07	C162847	48780-1	d6a99b39-68ce-a426-e053-dadaa90af4c2	Major Cold & Hot patch, 5ct in resealable pouch (69401)
0904-5694-01	2022-01-28	C162847	48780-1	d6a99b39-68ce-a426-e053-dadaa90af4c2	Major Cold & Hot patch, 5ct in resealable pouch (69401)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5694-01	EA - Each	0904-5694	c4646f21-4e64-4ac4-aad1-c37b877d931b	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
SODIUM POLYMETAPHOSPHATE	INACTIVE INGREDIENT	P1BM4ZH95L	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5694-01	00904569401	1 POUCH in 1 PACKAGE (0904-5694-01) > 5 PATCH in 1 POUCH	1 pouch	2013-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Cold & Hot patch, 5ct in resealable pouch (69401)	Major Pharmaceuticals	2017-12-04	HUMAN OTC DRUG LABEL	3