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 50 of 164 · 3,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HCS Alcohol Prep Pad LargeISOPROPYL ALCOHOLConcordance Healthcare Solutions, LLC.3c4b14ca-3ff1-4a55-a239-31bfb5b3aaa52026-01-12WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLHART Health8d01b10b-7916-420e-9d44-ebd3806fe3152026-01-12WarningsExact identifier
unii: ND2M416302
MamisanLIDOCAINE HYDROCHLORIDE, MENTHOLMiramar Cosmetics, Inc DBA Miramar Lab4402e900-c6e9-4f32-8cc4-c84014384a9f2026-01-12WarningsExact identifier
unii: L7T10EIP3A
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacy022c3083-c611-47d0-aa93-d6c7612e7a472026-01-11WarningsExact identifier
unii: L7T10EIP3A
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacybf73d15a-9d68-42fa-bfee-d25748215f972026-01-11WarningsExact identifier
unii: L7T10EIP3A
LubracaneLUBRACANEOzeion LLC7c503e3e-1987-4027-8a43-12acf2cb548a2026-01-10WarningsExact identifier
unii: L7T10EIP3A
Vascu-Pro T009CACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltd01d22fd6-7d2f-4448-81ff-c88baafc0af72026-01-09WarningsExact identifier
unii: 02F3473H9O
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.b58145c6-0f6c-5a47-e053-2995a90a5d7f2026-01-09WarningsExact identifier
unii: ND2M416302
HyVee Throat Drops Lemon MintMENTHOLHY-VEE, INC47f738cc-7968-cc07-e063-6294a90af7ab2026-01-09WarningsExact identifier
unii: L7T10EIP3A
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-OnMENTHOLInspec Solutions12ff9b9a-73e5-ce31-e063-6294a90aeaf82026-01-09WarningsExact identifier
unii: L7T10EIP3A
ISOPROPYL RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLJC SALES1f3466d2-6a2e-f871-e063-6394a90af0852026-01-09WarningsExact identifier
unii: ND2M416302
HyVee Cough Drops Original HerbMENTHOLHY-VEE, INC47f81e54-0ce4-439d-e063-6294a90a2abe2026-01-09WarningsExact identifier
unii: L7T10EIP3A
Isopropyl AlcoholISOPROPYL ALCOHOLEpic Medical Supply Corp.04ac8597-00fa-458f-a929-ada5042a8c382026-01-09WarningsExact identifier
unii: ND2M416302
2.5% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLCc842544a-6aea-42af-a77e-7b202371b3872026-01-09WarningsExact identifier
unii: L7T10EIP3A
4% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLC7fb95135-4151-4ef4-bb6d-75251cafff6c2026-01-09WarningsExact identifier
unii: L7T10EIP3A
Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEMeijer Distribution, Inc781f89c0-94ab-48de-9e0b-decb37bcde462026-01-09WarningsExact identifier
unii: L7T10EIP3A
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 02F3473H9O
PAIN RELIEF Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd22d9ce20-1cb6-c5bd-e063-6394a90a9eca2026-01-08WarningsExact identifier
unii: L7T10EIP3A
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
unii: ND2M416302
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INT'L THERMO ANALGETICS ROLL-ON76ef713b-e23d-7b98-e053-2991aa0aad512026-01-08WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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