MEDROX

Product NDC: 68788-6755
11-digit product format: 687886755
Labeler code: 68788
Product ID: 68788-6755_63eea2b9-bea1-4347-a6ed-222d5f749d86
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, CAPSAICIN
Dosage form: PATCH
Route: TOPICAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-07-27
Marketing end: 0000-00-00
Substance: MENTHOL, UNSPECIFIED FORM; CAPSAICIN
Active strength: 5 g/100g; g/100g
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-6755		I	Inactivated by FDA	2026-11-13
excluded package	package	68788-6755	68788-6755-3	I	Inactivated by FDA	2026-11-13
excluded package	package	68788-6755	68788-6755-5	I	Inactivated by FDA	2026-11-13

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6755-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6755-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6755-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6755-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-6755-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-6755-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-6755-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-6755-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-6755-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-6755-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-6755-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-6755-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-6755-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-6755-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-6755-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-6755-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-6755-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-6755-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-6755-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-6755-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-6755-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-6755-5	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-6755-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-6755-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68788-6755-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68788-6755-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68788-6755-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68788-6755-5	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68788-6755-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68788-6755-5	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68788-6755-5	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68788-6755-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68788-6755-5	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68788-6755-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68788-6755-5	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68788-6755-3	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68788-6755-5	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68788-6755-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68788-6755-5	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68788-6755-3	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68788-6755-3	2020-01-31	C162847	48780-1	9d75b9d0-f2d4-f424-e053-dadaa90a57ce	MEDROX PATCH
68788-6755-5	2020-01-31	C162847	48780-1	9d75b9d0-f2d4-f424-e053-dadaa90a57ce	MEDROX PATCH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-6755-3	MEDROX	30 in 1 BAG	PATCH	30	4
68788-6755-3	MEDROX	10 g in 1 PATCH	PATCH	10	4
68788-6755-5	MEDROX	10 g in 1 PATCH	PATCH	10	4
68788-6755-5	MEDROX	5 in 1 BOX	PATCH	5	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-6755	MEDROX (MENTHOL, CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS, INC.]	4	Legacy NDC, 4 package rows	20171221_5b171000-a3d7-4adf-817f-1eba14773e0a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1300889	capsaicin 0.0375 % / menthol 5 % Medicated Patch	PSN	5b171000-a3d7-4adf-817f-1eba14773e0a	4
1300889	capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG Medicated Patch	SCD	5b171000-a3d7-4adf-817f-1eba14773e0a	4
1300889	capsaicin 0.0375 % / menthol 5 % Medicated Patch	SY	5b171000-a3d7-4adf-817f-1eba14773e0a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68788-6755-3	68788675503	30 in 1 BAG		Historical
68788-6755-5	68788675505	10 g in 1 PATCH	10 g	Historical