Medrox

Product NDC: 45861-009
11-digit product format: 458610009
Labeler code: 45861
Product ID: 45861-009_c7f9ca4a-b147-454f-86b5-29bed05500a4
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol, CAPSAICIN, methyl salicylate
Dosage form: PATCH
Route: TOPICAL
Labeler: Pharmaceutica North America, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-10-27
Marketing end: 0000-00-00
Substance: MENTHOL; CAPSAICIN; METHYL SALICYLATE
Active strength: 5 g/100g; g/100g; g/100g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45861-009		D	Discontinued by firm	2026-10-05
excluded product	product	45861-009		D	Discontinued by firm	2026-10-05
excluded package	package	45861-009	45861-009-06	D	Discontinued by firm	2026-10-05
excluded package	package	45861-009	45861-009-05	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 2 · 88 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 product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45861-009-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45861-009-06	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 product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45861-009-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45861-009-06	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 product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45861-009-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45861-009-06	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 product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45861-009-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45861-009-06	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 product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45861-009-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45861-009-06	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 product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45861-009-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45861-009-06	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 product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45861-009-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45861-009-06	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 product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45861-009-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45861-009-06	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 product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45861-009-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45861-009-06	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45861-009-06	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45861-009-05	I	Inactivated by FDA	`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 product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45861-009-06	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45861-009-05	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 product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45861-009-06	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45861-009-05	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 product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	45861-009-06	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	45861-009-05	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 product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	45861-009-06	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	45861-009-05	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 product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	45861-009-06	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	45861-009-05	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
45861-009-05	2024-12-24	9d75b9d1-1668-f424-e053-dadaa90a57ce	Medrox Patch
45861-009-06	2024-12-24	9d75b9d0-9310-f424-e053-dadaa90a57ce	Medrox Patch 5%
45861-009-05	2020-01-31	9d75b9d1-1668-f424-e053-dadaa90a57ce	Medrox Patch
45861-009-06	2020-01-31	9d75b9d0-9310-f424-e053-dadaa90a57ce	Medrox Patch 5%

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
DISODIUM SULFOSALICYLATE	INACTIVE INGREDIENT	WFP6MAA96R	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
water	INACTIVE INGREDIENT	059QF0KO0R	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	14
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
methyl salicylate	ACTIVE INGREDIENT	LAV5U5022Y	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
Menthol	ACTIVE MOIETY	L7T10EIP3A	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
DISODIUM SULFOSALICYLATE	INACTIVE INGREDIENT	WFP6MAA96R	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5
water	INACTIVE INGREDIENT	059QF0KO0R	MEDROX (MENTHOL, CAPSAICIN, METHYL SALICYLATE) PATCH [PHARMACEUTICA NORTH AMERICA, INC.]	5

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Medrox Patch	Pharmaceutica North America, Inc.	2014-12-01	HUMAN OTC DRUG LABEL	14
Medrox Patch 5%	Pharmaceutica North America, Inc. \| SMARTDATA SUZHOU CO., Ltd	2014-12-01	HUMAN OTC DRUG LABEL	5

Medrox

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#