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 82 of 132 · 2,639 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MARS WELLNESS MAGNESIUMMENTHOLRENU LABORATORIES, LLCdae7673c-4352-b9d7-e053-2995a90a96da2025-05-14WarningsExact identifier
unii: 101I4J0U34
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
SORE NO MORE WARM THERAPYMENTHOL AND CAMPHORSOMBRA COSMETICS INC.cd86b56e-9b4c-4aca-9740-c8793cb120552025-05-12WarningsExact identifier
unii: L7T10EIP3A
SORE NO MORE COOL THERAPYMENTHOLSOMBRA COSMETICS INC.9aa1f0ac-3baf-4e45-9e3a-c28a99b229092025-05-12WarningsExact identifier
unii: L7T10EIP3A
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC67bee807-7ba8-4e92-81f2-c888118d277e2025-05-09Exact identifier
unii: 02F3473H9O
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0fb30b7e-8e1b-49c7-afac-2d5c01b9ff452025-05-09Exact identifier
unii: 02F3473H9O
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb0f2c9a2-d9d4-4907-a324-e7a26d489f442025-05-09Exact identifier
unii: 02F3473H9O
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCa829d4eb-3ec5-453c-b270-793969af15b32025-05-09Exact identifier
unii: 02F3473H9O
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLC5bf31b49-24c8-4021-98da-33a151f2fcbe2025-05-08Exact identifier
unii: 02F3473H9O
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC50fc30a0-0eca-452e-825e-08c2647ccfc12025-05-08Exact identifier
unii: 02F3473H9O
ChamosynBARRIER CREAMLinks Medical Productsf9dfb2d7-4684-4525-994e-1e0ff90413d92025-05-08WarningsExact identifier
unii: L7T10EIP3A
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCe18bacfe-af60-49dc-bd30-cb3c29fa16db2025-05-07Exact identifier
unii: 02F3473H9O
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLC2b327b13-a0e9-4b2c-9875-4470998e2e302025-05-07Exact identifier
unii: 02F3473H9O
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb2b780d3-26ac-4e7c-a0f2-78991bee32a82025-05-07Exact identifier
unii: 02F3473H9O
LANOZEM HEMORRHOIDALMENTHOL, PETROLATUMSod-e Biotech Ltd34901e83-8f24-8460-e063-6394a90a27442025-05-07WarningsExact identifier
unii: L7T10EIP3A
Good Neighbor Muscle Rub CreamCAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%,Amerisource Bergen34924bb9-e3e8-70e6-e063-6294a90aaa8c2025-05-07WarningsExact identifier
unii: L7T10EIP3A
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee0235-5a6e-0ea1-e063-6394a90a89a52025-05-06WarningsExact identifier
unii: L7T10EIP3A
Plantar Fasciitis Pain Relief Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd34838622-b092-afeb-e063-6294a90ae7db2025-05-06WarningsExact identifier
unii: L7T10EIP3A
LidotholLIDOCAINE HCL, MENTHOLAdvanced Rx of Tennessee, LLC3467f4c7-122c-40df-e063-6394a90ae36e2025-05-05Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Menthol Pain Relieving Cream with Menthol 10%MENTHOL 10% CREAMONE2ZEE LIMITED LIABILITY COMPANYae09e93f-3988-4477-ae53-b2f3df9769fb2025-05-05WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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