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 17 of 165 · 3,288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
myDerm MEDICAL NEW Soothing HemorrhoidalWITCH HAZEL PENYLEPHRINE LIDOCAINEInspec Solutions2ff42501-7730-42de-99dd-6fc53bbdf25f2026-05-27WarningsExact identifier
unii: 101I4J0U34
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLC.d427d623-c2fd-7d6b-e053-2995a90abdc32026-05-27WarningsExact identifier
unii: L7T10EIP3A
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFBENZOCAINE AND MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6140d487-d87c-4954-9247-83492bcc57382026-05-27WarningsExact identifier
unii: L7T10EIP3A
MyMedic Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd52b5653e-289c-d99e-e063-6294a90aa6472026-05-26WarningsExact identifier
unii: ND2M416302
Lidothol ESMENTHOL 5%, LIDOCAINE 4%Advanced Rx of Tennessee, LLC49ef3680-e34e-1fe7-e063-6294a90a959f2026-05-26Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
unii: L7T10EIP3A
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)POVIDONE-IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD529b8ad6-081e-0ef8-e063-6294a90a67df2026-05-24WarningsExact identifier
unii: ND2M416302
Swab Stick 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA)CHLORHEXIDINE GLUCONATE, ISOPROPYI ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD51c42761-3a7a-172d-e063-6394a90a53332026-05-24WarningsExact identifier
unii: ND2M416302
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact identifier
unii: L7T10EIP3A
Walgreens 70% Isopropyl Alcohol WipesISOPROPYL ALCOHOLWalgreen Companye8b0ecc3-3a30-47c9-b7d1-518681d575b42026-05-21WarningsExact identifier
unii: ND2M416302
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEPreferred Pharmaceuticals Inc.6c9a076e-6316-427b-9ce6-c8fe2d3888372026-05-21WarningsExact identifier
unii: L7T10EIP3A
70% Isopropyl Alcohol70% ISOPROPYL ALCOHOLGreatdealson, Inc.4aa809cd-500a-dd65-e063-6394a90a31442026-05-20Warnings, Adverse reactionsExact identifier
unii: ND2M416302
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRockland Cosmetics, Inc.1bbae739-5e54-64cb-e063-6294a90a37452026-05-20Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRockland Cosmetics, Inc.b7c63ae5-08a8-436a-bbaa-f3ab3c2a5e672026-05-20Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
CVS Isopropyl Rubbing Alcohol WipesISOPROPYL ALCOHOLCVS PHARMACY, INC7e027210-9729-4659-8a75-b6b2ac60f7bc2026-05-19WarningsExact identifier
unii: ND2M416302
CVS Isopropyl Rubbing Alcohol PadsISOPROPYL ALCOHOLCVS PHARMACY, INCe65b3363-71d9-47b6-a044-edac18f9858f2026-05-19WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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