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 26 of 132 · 2,639 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntisepticEUCALYPTOL, MENTHOL, METYL SALICYLATE, THYMOLWalmart Inc.404dfa0f-8ac1-463a-9e10-fc87f70697952026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalmart Inc.d2515c9c-79b4-4874-be6e-fe8312477fc82026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalmart Inc.4da4ecf6-038e-4a64-83f7-c29d70e831742026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
unii: L7T10EIP3A
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
unii: L7T10EIP3A
Advanced Pain Relief Cream With 5 % Natural MentholMENTHOLAllure Labs4bab9c43-86d4-dad2-e063-6394a90ac0952026-02-25WarningsExact identifier
unii: L7T10EIP3A
Walgreens Pain Relieving PatchMENTHOL, CAMPHOR, METHYL SALICYLATEWalgreen Co.4223c74a-12fb-51a3-e063-6294a90a0deb2026-02-25WarningsExact identifier
unii: L7T10EIP3A
Advanced Pain Relief Roll-On Gel With 5% Natural MentholMENTHOLAllure Labs4bad597f-acb2-a122-e063-6394a90a9fcf2026-02-25WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLBetter Living Brands, LLCc2c6a591-c2fd-47ac-bf80-41e6030fdd752026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Witch HazelWITCH HAZELBetter Living Brands, LLC0355edab-b6f7-4e59-bce1-cf6a8897b9892026-02-24Warnings, Adverse reactionsExact identifier
unii: 101I4J0U34
Antiseptic Rinse Spring MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar Stores, Inc974e97c5-a255-4bb4-9ec9-5edc3f7899eb2026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFamily Dollar Stores, Inc1b50b865-3dfc-4b3f-86d5-5e91ca7724452026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar Stores, Inc7a581e30-b062-498c-aefa-8fad58517afc2026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar Stores, Inc7b6563bc-8aa7-48ea-bf1c-5d5a5ee2d3812026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar controlEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar Stores, Incc74250c1-785e-49da-9e53-88007bdfdaf52026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLH E Bf1450866-1be4-46d9-9fe4-52d699636b4f2026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLMajor Pharmaceuticals11416620-4892-44ba-9780-db27efff67432026-02-24WarningsExact identifier
unii: L7T10EIP3A
Family Wellness SF Honey Lemon Cough DropsMENTHOLFamily Dollar4437853d-1f42-a41d-e063-6294a90aa81e2026-02-24WarningsExact identifier
unii: L7T10EIP3A
dermaFIT Muscle Retention Cream StrengthMENTHOLEX Healthcare Inc.4620c41a-2187-00f5-e063-6394a90a613c2026-02-23WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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