FDA.reportPublic FDA data

XtraCare Ice Cold Topical Analgesic Gel

Product NDC
58503-052
Requested package NDC
58503-052-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58503-05258503-052-01IInactivated by FDA2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-052-012024-01-30C16284748780-11030e365-3fa5-111a-e063-dadaa90a10e2XtraCare Ice Cold Topical Analgesic Gel
58503-052-022024-01-30C16284748780-11030e365-3fa5-111a-e063-dadaa90a10e2XtraCare Ice Cold Topical Analgesic Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-052-01XtraCare Ice Cold Topical Analgesic Gel227 g in 1 BOTTLEGEL2275
58503-052-02XtraCare Ice Cold Topical Analgesic Gel227 g in 1 TUBEGEL2275

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2
MENTHOLACTIVE MOIETYL7T10EIP3AXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-052XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]5Legacy NDC, 2 package rows20180806_a76f6abe-37cf-459f-96e3-7dd60b6d5723.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866128menthol 1.25 % Topical GelPSNa76f6abe-37cf-459f-96e3-7dd60b6d57235
866128menthol 0.0125 MG/MG Topical GelSCDa76f6abe-37cf-459f-96e3-7dd60b6d57235
866128menthol 1.25 % Topical GelSYa76f6abe-37cf-459f-96e3-7dd60b6d57235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-052-0158503005201227 g in 1 BOTTLE (58503-052-01) 227 g2014-01-300000-00-00NoNoCurrent