Ice Cold Topical Analgesic Gel

Product NDC: 58503-007
Requested package NDC: 58503-007-01
11-digit product format: 585030007
Labeler code: 58503
Product ID: 58503-007_edb156ce-6526-42fa-e053-2a95a90a4057
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: 2013-05-24
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 3 mg/227mg
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58503-007	58503-007-01	I	Inactivated by FDA		2026-08-17

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58503-007-01	2025-01-30	C162847	48780-1	2cef2736-8ef1-d83d-e063-dadaa90ab31f	Ice Cold Topical Analgesic Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58503-007-01	Ice Cold Topical Analgesic Gel	237 mg in 1 BOTTLE	GEL	237		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58503-007	ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	3	Legacy NDC, 1 package rows	20221118_50e7d221-d73a-4550-9a7e-8d33a3910629.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866128	menthol 1.25 % Topical Gel	PSN	50e7d221-d73a-4550-9a7e-8d33a3910629	3
866128	menthol 0.0125 MG/MG Topical Gel	SCD	50e7d221-d73a-4550-9a7e-8d33a3910629	3
866128	menthol 1.25 % Topical Gel	SY	50e7d221-d73a-4550-9a7e-8d33a3910629	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58503-007-01	58503000701	237 mg in 1 BOTTLE (58503-007-01)	237 mg	2013-05-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ice Cold Topical Analgesic Gel	China Ningbo Shangge Cosmetic Technology Corp.	2022-11-17	HUMAN OTC DRUG LABEL	3