Soothanol X2

Product NDC: 50972-766
11-digit product format: 509720766
Labeler code: 50972
Product ID: 50972-766_cc878010-66e4-4cd0-8282-33ef5142ff10
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin and Menthol
Dosage form: SOLUTION/ DROPS
Route: TOPICAL
Labeler: NewMarket Health Products LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-06-11
Marketing end: 0000-00-00
Substance: CAPSAICIN; MENTHOL
Active strength: 2 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2019-12-31
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	50972-766		I	Inactivated by FDA		2026-10-05
excluded package	package	50972-766	50972-766-01	I	Inactivated by FDA		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 · 42 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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`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	50972-766-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	50972-766-01	`9bebd1f3094a…`	`5416666fcb17…`

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
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50972-766-01	2020-01-31	C162847	48780-1	9d75b9cf-dd1b-f424-e053-dadaa90a57ce	Soothanol X2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50972-766-01	Soothanol X2	28.3 g in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	28.3		2
50972-766-01	Soothanol X2	1 in 1 BOX	SOLUTION/ DROPS	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
ARNICA ANGUSTIFOLIA FLOWER	INACTIVE INGREDIENT	NG0U89QRD8	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
DIMETHYL SULFOXIDE	INACTIVE INGREDIENT	YOW8V9698H	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
EMU OIL	INACTIVE INGREDIENT	344821WD61	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
LIMONENE, (+)-	INACTIVE INGREDIENT	GFD7C86Q1W	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1
ST. JOHN'S WORT	INACTIVE INGREDIENT	UFH8805FKA	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50972-766	SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]	2	Legacy NDC, 2 package rows	20170911_29ea4b34-dff7-40de-82b4-9b2dd1eb32ca.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1540500	capsaicin 0.2 % / menthol 12 % Topical Solution	PSN	29ea4b34-dff7-40de-82b4-9b2dd1eb32ca	2
1540505	SOOTHANOL X2 0.2 % / 12 % Topical Solution	PSN	29ea4b34-dff7-40de-82b4-9b2dd1eb32ca	2
1540505	capsaicin 2 MG/ML / menthol 120 MG/ML Topical Solution [Soothanol X2]	SBD	29ea4b34-dff7-40de-82b4-9b2dd1eb32ca	2
1540500	capsaicin 2 MG/ML / menthol 120 MG/ML Topical Solution	SCD	29ea4b34-dff7-40de-82b4-9b2dd1eb32ca	2
1540500	capsaicin 0.2 % / menthol 12 % Topical Solution	SY	29ea4b34-dff7-40de-82b4-9b2dd1eb32ca	2
1540505	Soothanol X2 (capsaicin 0.2 % / menthol 12 % ) Topical Solution	SY	29ea4b34-dff7-40de-82b4-9b2dd1eb32ca	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50972-766-01	50972076601	28.3 g in 1 BOTTLE, DROPPER	28.3 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Soothanol X2	NewMarket Health Products LLC \| Vitality Works, Inc.	2017-08-31	HUMAN OTC DRUG LABEL	2