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 16 of 166 · 3,319 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Witch HazelWITCH HAZELCVS Pharmacy, Inc.50f920da-b41a-480d-b3a0-df940caaee2d2026-06-08Warnings, Adverse reactionsExact identifier
unii: 101I4J0U34
MedThermal ALCOHOL PREP PADISOPROPYL ALCOHOLCarelife (USA) Inc.fc9d6344-be68-484f-984b-8c7f39b6034d2026-06-08WarningsExact identifier
unii: ND2M416302
GeriGentle Alcohol PadsISOPROPYL ALCOHOLGeri-Gentle Corporation05cda9fa-e503-6e37-e063-6394a90a27112026-06-05WarningsExact identifier
unii: ND2M416302
GNP Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLAmerisource Bergen03247512-7a31-4fb4-b7e0-efc337cab6932026-06-04WarningsExact identifier
unii: ND2M416302
GNP Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLAmerisource Bergen0ffd9643-3bc2-4b04-92c5-80fe5e429a252026-06-04WarningsExact identifier
unii: ND2M416302
Maximum Strength Pain ReliefMENTHOL CREAMOWELL NATURALS LLC5388f2c5-8cfd-a601-e063-6294a90a2e5f2026-06-04WarningsExact identifier
unii: L7T10EIP3A
MG PLUS ROLL ONMENTHOL ROLL ONRENU LABORATORIES, LLC535dc42f-38c7-2afc-e063-6294a90ae23d2026-06-03WarningsExact identifier
unii: L7T10EIP3A
OP First Aid Series Insect Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.b43af183-834a-0f64-e053-2995a90a32182026-06-03WarningsExact identifier
unii: ND2M416302
Mineral Ice Extreme Dry StickMENTHOLCarlin Consumer Health LLC4f81be91-92e5-1205-e063-6394a90a6e822026-06-02WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Ultraflex PlusLIDOCAINE, MENTHOLReckitt Benckiser LLC401e1843-e9a6-fda9-e063-6294a90a30732026-06-02WarningsExact identifier
unii: L7T10EIP3A
OptiSource Sterile Alcohol Prep PadsISOPROPYL ALCOHOL7051395 Canada Ince49c9ddf-7743-443e-ba85-ee90785f0c722026-06-02WarningsExact identifier
unii: ND2M416302
Pain ReliefMENTHOL SPRAYOwell Naturals Brand, LLC534c871c-da35-6135-e063-6294a90aa9f62026-06-02WarningsExact identifier
unii: L7T10EIP3A
Fishermans Friend Mixed BerryMENTHOLLofthouse of Fleetwood53391c4d-ee2d-ade3-e063-6394a90ac77d2026-06-01WarningsExact identifier
unii: L7T10EIP3A
Orajel Medicated for Toothache and Gum, LiquidBENZOCAINE AND MENTHOLChurch & Dwight Co., Inc.ac3d605d-241d-1a6f-e053-2a95a90ae3912026-06-01WarningsExact identifier
unii: L7T10EIP3A
BM HOMOEOLAXALOE SOCO, BRYONIA ALBA, CROTON TIG, HYDRASTIS CAN, ALUMEN, MAG MUR, PHENOLPHTHALEINBM Private Limited5324c47d-d085-dca0-e063-6394a90a92f92026-05-31WarningsExact identifier
unii: 02F3473H9O
Careland Kinesiology Pain Relieving TapeCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.35d24cfc-9d34-4fd7-9312-1673b092a3b92026-05-31WarningsExact identifier
unii: L7T10EIP3A
EpidiolexCANNABIDIOLJazz Pharmaceuticals, Inc.8bf27097-4870-43fb-94f0-f3d0871d1eec2026-05-29Warnings, Adverse reactionsExact identifier
unii: 19GBJ60SN5
Belladona and ArnicaMENTHOLDannso Corp./d.b.a. Essential Productsfc4e63e4-cebc-49ff-8900-7238261d0fe02026-05-28WarningsExact identifier
unii: L7T10EIP3A
LidotholLIDOCAINE HCL, MENTHOLASCLEMED USA INC.4e2fad18-13f1-4e61-86db-d721029287172026-05-28Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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