Ice Cold Topical Analgesic Gel

Product NDC
58503-007
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-007-012025-01-30C16284748780-12cef2736-8ef1-d83d-e063-dadaa90ab31fIce Cold Topical Analgesic Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-007-01Ice Cold Topical Analgesic Gel237 mg in 1 BOTTLEGEL2373

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
MENTHOLACTIVE MOIETYL7T10EIP3AICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-007ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3Legacy NDC, 1 package rows20221118_50e7d221-d73a-4550-9a7e-8d33a3910629.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866128menthol 1.25 % Topical GelPSN50e7d221-d73a-4550-9a7e-8d33a39106293
866128menthol 0.0125 MG/MG Topical GelSCD50e7d221-d73a-4550-9a7e-8d33a39106293
866128menthol 1.25 % Topical GelSY50e7d221-d73a-4550-9a7e-8d33a39106293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-007-0158503000701237 mg in 1 BOTTLE (58503-007-01) 237 mg2013-05-240000-00-00NoNoCurrent