FDA.reportPublic FDA data

NDC 76348-570-03 - AK47 Cooling Roll-On

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
76348-570
Requested NDC
76348-570-03
Package NDCs from labels
76348-570-03, 76348-570-01
Manufacturer
Renu Laboratories, Inc.
Effective date
2020-08-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AK4 7 Cooling Roll-On Pain ReliefRenu Laboratories, Inc.2020-08-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-570-012022-01-28C16284748780-1d6a99b39-cf94-a426-e053-dadaa90af4c2AK4 7 Cooling Roll-On Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-570-01AK47 Cooling Roll-On1 in 1 BOXLIQUID11
76348-570-03AK47 Cooling Roll-On84 g in 1 APPLICATORLIQUID841

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-570AK47 COOLING ROLL-ON (MENTHOL ROLL-ON) LIQUID [RENU LABORATORIES, INC.]1Legacy NDC, 2 package rows20200812_ac9ba695-afa3-118f-e053-2a95a90a8168.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 29 of 164 · 3,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Harris Teeter SF Honey Lemon Cough DropsMENTHOLHarris Teeter4d524b45-260e-7411-e063-6294a90af6392026-03-18WarningsExact identifier
unii: L7T10EIP3A
MiloRod Ultra Muscle Rub Fast-Acting Pain ReliefCAPSAICIN, MENTHOLMilo Rod Import & Export, Inc.c3622dc3-0c05-47c9-b70b-4989467819062026-03-17WarningsExact identifier
unii: L7T10EIP3A
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Lidothol GelLIDOTHOL GELDirect_Rx34f15ceb-87c1-526d-e063-6294a90a37892026-03-17Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC8d9961f0-1ecf-d7fb-b6b4-856d636d68e12026-03-17WarningsExact identifier
unii: 101I4J0U34
MedPRIDEISOPROPYL ALCOHOLShield Line LLCf2177bd3-259d-4231-88b2-4a98e48e4df62026-03-17WarningsExact identifier
unii: ND2M416302
MedPride 91% Rubbing AlcoholISOPROPYL ALCOHOLShield Line LLCe6ffe41e-efdc-0e0a-e053-2995a90a9e6a2026-03-17WarningsExact identifier
unii: ND2M416302
MedPRIDE with Wintergreen OilISOPROPYL ALCOHOLShield Line LLC57ac1a5c-758a-4422-8795-40391584434a2026-03-17WarningsExact identifier
unii: ND2M416302
NOVITA ISOPROPYL ALCOHOL 50%ISOPROPYL ALCOHOLShield Line LLC3ad79e91-377d-6587-e054-00144ff8d46c2026-03-17WarningsExact identifier
unii: ND2M416302
NOVITA 50% ISOPROPYL RUBBING ALCOHOL W/ WINTERGREENISOPROPYL ALCOHOLShield Line LLC3bd9fc61-b135-51f5-e054-00144ff8d46c2026-03-17WarningsExact identifier
unii: ND2M416302
Lidothol PatchLIDOTHOL PATCHDirect_Rx1987e839-6f4e-8671-e063-6394a90abea62026-03-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
CVS Muscle BalmMENTHOL, CAMPHORCVS Health42796fc4-03be-3b02-e063-6394a90af2ab2026-03-16WarningsExact identifier
unii: L7T10EIP3A
CVS Health Pain Relief FootMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.0f646876-69d0-49db-ade2-2b3eb26dd3992026-03-16WarningsExact identifier
unii: L7T10EIP3A
Walgreens Cold Therapy Pain Relief Foot CreamMENTHOLWalgreen Co.3bc8ece3-d555-3efb-e063-6394a90a19812026-03-16WarningsExact identifier
unii: L7T10EIP3A
RICHTOFIT RAPID ACTIVE LEG AND FOOTMENTHOLRICHTOFIT LIMITED LIABILITY COMPANY4c357696-ca96-e6ad-e063-6294a90aaadb2026-03-16WarningsExact identifier
unii: L7T10EIP3A
Biopure Alcohol Cotton SwabsISOPROPYL ALCOHOL, COTTON SWABQUEST USA CORP3a60362b-b397-da15-e063-6394a90a45ff2026-03-15WarningsExact identifier
unii: ND2M416302
Xpect Stopain ClinicalMENTHOLCintas Corporation348e6062-b31e-435e-a153-6aa868b50efa2026-03-13WarningsExact identifier
unii: L7T10EIP3A
DGH GREASELESS MUSCLE RUB ANALGESICMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEDOLLAR GENERAL225abfe0-ec72-4667-96b2-7657e989672b2026-03-13WarningsExact identifier
unii: L7T10EIP3A
NUMBINGMENTHOLFlexiGo Inc4ce416dd-2430-4648-e063-6294a90ab1992026-03-13WarningsExact identifier
unii: L7T10EIP3A
CVS Professional Pain ReliefMENTHOLCVS Pharmacy48836a5b-0baa-b7ee-e063-6294a90ac12b2026-03-13WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.