FDA.reportPublic FDA data

NDC 76348-522-04 - AK47 MENTHOL COOLING

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
76348-522
Requested NDC
76348-522-04
Package NDCs from labels
76348-522-04, 76348-522-01
Manufacturer
RENU LABORATORIES, INC.
Effective date
2020-07-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AK4 7 Menthol Cooling Pain Relief CreamRENU LABORATORIES, INC.2020-07-23HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-522-012022-01-28C16284748780-1d6a99b39-43c4-a426-e053-dadaa90af4c2AK4 7 Menthol Cooling Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-522-01AK47 MENTHOL COOLING1 in 1 BOXCREAM12
76348-522-04AK47 MENTHOL COOLING112 g in 1 JARCREAM1122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-522AK47 MENTHOL COOLING (MENTHOL COOLING) CREAM [RENU LABORATORIES, INC.]2Legacy NDC, 2 package rows20200724_aae3c43a-3839-01ce-e053-2a95a90a885c.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 7 of 132 · 2,639 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Muscle Rub CreamMUSCLE RUB CREAMPreferred Pharmaceuticals Inc.ea209a4e-acad-413b-8fb9-27e98130bcd62026-07-28WarningsExact identifier
unii: L7T10EIP3A
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
LidoProLIDOCAINE AND MENTHOLClinic Pharmacdfd6b39-b430-4e95-a0f7-682cf3d78b522026-07-28WarningsExact identifier
unii: L7T10EIP3A
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
unii: L7T10EIP3A
HEMPE Ice Muscle and Joint GelMENTHOLHealthcare International Research Limited57aec922-1de4-c579-e063-6394a90af6c82026-07-28WarningsExact identifier
unii: L7T10EIP3A
Green bud SOOTHING MASSAGE FLUIDGREEN BUD SOOTHING MASSAGE FLUIDWANWANG INC57b01b7b-0ea9-f8c9-e063-6394a90a95c62026-07-28WarningsExact identifier
unii: L7T10EIP3A
Earths Care Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEDLC Laboratories, Inc.5c3976da-a6cb-4b94-ae41-3e86b1ab13cb2026-07-28WarningsExact identifier
unii: L7T10EIP3A
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Preferred Pharmaceuticals Inc.9e7568b6-52ae-4f7a-9bfd-503fd80a297e2026-07-28WarningsExact identifier
unii: L7T10EIP3A
KENS PAIN AND ARTHRITIS FORMULAMENTHOLEezaway Relief Inc35834473-3ad5-41ec-a110-e742aa7e2ee42026-07-28WarningsExact identifier
unii: L7T10EIP3A
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC57984bc2-bf1d-c423-e063-6394a90a06ae2026-07-27WarningsExact identifier
unii: L7T10EIP3A
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
unii: L7T10EIP3A
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
unii: L7T10EIP3A
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
unii: L7T10EIP3A
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
unii: L7T10EIP3A
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
unii: L7T10EIP3A
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
unii: L7T10EIP3A
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
unii: L7T10EIP3A
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
unii: L7T10EIP3A
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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