XOTEN-C

Product NDC: 64038-944
11-digit product format: 640380944
Labeler code: 64038
Product ID: 64038-944_8f97fcd2-08db-4b14-95c6-898c22188a2f
Type: HUMAN OTC DRUG
Nonproprietary name: Methyl salicylate, Menthol, Capsaicin
Dosage form: LOTION
Route: TOPICAL
Labeler: Living Well Pharmacy Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-08-01
Marketing end: 0000-00-00
Substance: METHYL SALICYLATE; MENTHOL; CAPSAICIN
Active strength: 20 g/100g; 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64038-944		I	Inactivated by FDA		2026-10-12
excluded package	package	64038-944	64038-944-01	I	Inactivated by FDA		2026-10-12

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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64038-944-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64038-944-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64038-944-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64038-944-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64038-944-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64038-944-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64038-944-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64038-944-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64038-944-01	I	Inactivated by FDA	`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 package	package	64038-944-01	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 package	package	64038-944-01	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	64038-944-01	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	64038-944-01	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	64038-944-01	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	64038-944-01	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	64038-944-01	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	64038-944-01	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	64038-944-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64038-944-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64038-944-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64038-944-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64038-944-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
64038-944-01	2020-01-31	C162847	48780-1	9d75b9d0-5af7-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64038-944-01	XOTEN-C	113.4 g in 1 BOTTLE	LOTION	113.4		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64038-944-01	GM - Gram	64038-944	1350bc17-f573-45e9-94d8-2b9a5210329d	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Capsaicin	ACTIVE INGREDIENT	S07O44R1ZM	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
Methyl salicylate	ACTIVE INGREDIENT	LAV5U5022Y	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
Capsaicin	ACTIVE MOIETY	S07O44R1ZM	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
Methyl salicylate	ACTIVE MOIETY	LAV5U5022Y	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
ARNICA MONTANA	INACTIVE INGREDIENT	O80TY208ZW	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
Ethylhexyl Palmitate	INACTIVE INGREDIENT	2865993309	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
METHYLDIBROMO GLUTARONITRILE	INACTIVE INGREDIENT	YX089CPS05	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64038-944	XOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [LIVING WELL PHARMACY INC.]	1	Legacy NDC, 1 package rows	20110808_1dcb64fd-6bc6-4375-8d30-4462e2407934.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1119597	capsaicin 0.002 % / menthol 10 % / methyl salicylate 20 % Topical Lotion	PSN	1dcb64fd-6bc6-4375-8d30-4462e2407934	1
1125493	XOTEN-C 0.002 % / 10 % / 20 % Topical Lotion	PSN	1dcb64fd-6bc6-4375-8d30-4462e2407934	1
1125493	capsaicin 0.02 MG/ML / menthol 100 MG/ML / methyl salicylate 200 MG/ML Topical Lotion [Xoten-C]	SBD	1dcb64fd-6bc6-4375-8d30-4462e2407934	1
1119597	capsaicin 0.02 MG/ML / menthol 100 MG/ML / methyl salicylate 200 MG/ML Topical Lotion	SCD	1dcb64fd-6bc6-4375-8d30-4462e2407934	1
1119597	capsaicin 0.002 % / menthol 10 % / methyl salicylate 20 % Topical Lotion	SY	1dcb64fd-6bc6-4375-8d30-4462e2407934	1
1125493	Xoten-C (capsaicin 0.002 % / menthol 10 % / methyl salicylate 20 % ) Topical Lotion	SY	1dcb64fd-6bc6-4375-8d30-4462e2407934	1
1125493	Xoten-C (capsaicin 0.02 MG / menthol 100 MG / methyl salicylate 200 MG) per ML Topical Lotion	SY	1dcb64fd-6bc6-4375-8d30-4462e2407934	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
64038-944-01	64038094401	113.4 g in 1 BOTTLE	113.4 g	Historical