XtraCare Ice Cold Topical Analgesic Gel

Product NDC: 58503-052
11-digit product format: 585030052
Labeler code: 58503
Product ID: 58503-052_72c50c9b-c877-2e62-e053-2a91aa0a7785
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: China Ningbo Shangge Cosmetic Technology Corp
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-01-30
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 3 g/227g
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58503-052		I	Inactivated by FDA	2026-10-05
excluded package	package	58503-052	58503-052-01	I	Inactivated by FDA	2026-10-05
excluded package	package	58503-052	58503-052-02	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 · 45 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	58503-052-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58503-052-01	`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	58503-052-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58503-052-01	`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	58503-052-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58503-052-01	`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	58503-052-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58503-052-01	`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	58503-052-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58503-052-01	`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	58503-052-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58503-052-01	`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	58503-052-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58503-052-01	`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	58503-052-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58503-052-01	`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	58503-052-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58503-052-01	`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	58503-052-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58503-052-01	`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	58503-052-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58503-052-01	`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	58503-052-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58503-052-01	`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	58503-052-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58503-052-01	`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	58503-052-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58503-052-01	`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	58503-052-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58503-052-01	`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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58503-052-01	2024-01-30	C162847	48780-1	1030e365-3fa5-111a-e063-dadaa90a10e2	XtraCare Ice Cold Topical Analgesic Gel
58503-052-02	2024-01-30	C162847	48780-1	1030e365-3fa5-111a-e063-dadaa90a10e2	XtraCare Ice Cold Topical Analgesic Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58503-052-01	XtraCare Ice Cold Topical Analgesic Gel	227 g in 1 BOTTLE	GEL	227		5
58503-052-02	XtraCare Ice Cold Topical Analgesic Gel	227 g in 1 TUBE	GEL	227		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58503-052	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]	5	Legacy NDC, 2 package rows	20180806_a76f6abe-37cf-459f-96e3-7dd60b6d5723.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866128	menthol 1.25 % Topical Gel	PSN	a76f6abe-37cf-459f-96e3-7dd60b6d5723	5
866128	menthol 0.0125 MG/MG Topical Gel	SCD	a76f6abe-37cf-459f-96e3-7dd60b6d5723	5
866128	menthol 1.25 % Topical Gel	SY	a76f6abe-37cf-459f-96e3-7dd60b6d5723	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58503-052-01	58503005201	227 g in 1 BOTTLE (58503-052-01)	227 g	2014-01-30	0000-00-00	No	No	Current
58503-052-02	58503005202	227 g in 1 TUBE (58503-052-02)	227 g	2014-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Ice Cold Topical Analgesic Gel	China Ningbo Shangge Cosmetic Technology Corp \| China Ningbo Shangge Cosmetic Technology Corp.	2018-08-06	HUMAN OTC DRUG LABEL	5