FDA.reportPublic FDA data

NDC 76348-576-04 - AK47 Menthol Cooling Cream Packet

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
76348-576
Requested NDC
76348-576-04
Package NDCs from labels
76348-576-04, 76348-576-10
Manufacturer
RENU LABORATORIES, INC.
Effective date
2020-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AK4 7 MENTHOL COOLING CREAM PACKETRENU LABORATORIES, INC.2020-08-25HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-576-102022-01-28C16284748780-1d6a99b39-af63-a426-e053-dadaa90af4c2AK4 7 MENTHOL COOLING CREAM PACKET

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-576-04AK47 Menthol Cooling Cream Packet4 g in 1 PACKETCREAM41
76348-576-10AK47 Menthol Cooling Cream Packet10 in 1 BOXCREAM101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-576AK47 MENTHOL COOLING CREAM PACKET (MENTHOL) CREAM [RENU LABORATORIES, INC.]1Legacy NDC, 2 package rows20200827_adb83c12-6e29-8c70-e053-2a95a90a2761.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 80 of 131 · 2,618 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Free and Pure Cold Therapy Pain ReliefMENTHOLWalgreen Co.22cbbffc-f876-411e-e063-6394a90a1b382025-06-12WarningsExact identifier
unii: L7T10EIP3A
PLANTAR FASCIITIS Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd37570149-dae1-a4f2-e063-6294a90a32452025-06-11WarningsExact identifier
unii: L7T10EIP3A
Diabecin CS CreamMENTHOL, CAPSAICINPuretek Corporation33ef2233-7a66-ee65-e063-6294a90ac55a2025-06-10WarningsExact identifier
unii: L7T10EIP3A
KINKAN COOLDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLKINKANDO CO., LTD .82011efe-825c-4102-b6f1-59eff4c8040a2025-06-10WarningsExact identifier
unii: L7T10EIP3A
3% Menthol plus 0.083% Capsaicin Pain Relief PatchPAIN RELIEF PATCH, PAIN RELIEF STRIPXuzhou Lanting Pharmaceutical Co., Ltd378a6887-c609-b79c-e063-6394a90a00f42025-06-10WarningsExact identifier
unii: L7T10EIP3A
5% Menthol Pain Relief PatchPAIN RELIEF PATCHXuzhou Lanting Pharmaceutical Co., Ltd37895254-c092-1200-e063-6394a90a51b72025-06-10WarningsExact identifier
unii: L7T10EIP3A
5% Menthol Pain Relief PatchPAIN RELIEF PATCHXuzhou Lanting Pharmaceutical Co., Ltd37ea68d7-5c1f-cec8-e063-6294a90a709d2025-06-10WarningsExact identifier
unii: L7T10EIP3A
ORTHOGEL Menthol 3.5% Roll OnMENTHOLLiquidCapsule Manufacturing LLC99424327-67e9-43b5-a117-94c9643413c12025-06-07WarningsExact identifier
unii: L7T10EIP3A
Lightning Pain ReliefMENTHOLEbanel Laboratories, Inc36edbc3f-501c-c1ea-e063-6394a90af6af2025-06-06WarningsExact identifier
unii: L7T10EIP3A
FREEZE IT Menthol Roll OnMENTHOLLiquidCapsule Manufacturing LLC33094afe-db9d-4b92-8047-6dd611484fc92025-06-05WarningsExact identifier
unii: L7T10EIP3A
FREEZE IT MentholMENTHOLLiquidCapsule Manufacturing LLCde8d8007-5718-4fb4-a8c6-4650d2ca9c8f2025-06-05WarningsExact identifier
unii: L7T10EIP3A
HEEL PAIN Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36bacb5f-c1af-2e97-e063-6394a90afe5c2025-06-04WarningsExact identifier
unii: L7T10EIP3A
HealthWise Lidocaine and MentholLIDOCAINE AND MENTHOLVeridian Healthcare36c27642-f913-1aad-e063-6294a90a43432025-06-04WarningsExact identifier
unii: L7T10EIP3A
HealthWise Ultra OTC Strength Pain Relief CreamCAMPHOR, MENTHOL, AND METHYL SALICYLATEVeridian Healthcare36c3bbf9-a559-4c0d-e063-6394a90a8a1a2025-06-04WarningsExact identifier
unii: L7T10EIP3A
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
unii: L7T10EIP3A
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RE-LEVEMENTHOLSOMBRA COSMETICS INC.b4b39d79-0439-41e7-adca-e5ccb8f44e402025-05-29WarningsExact identifier
unii: L7T10EIP3A
PAIN NO MORE THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.f7bacc8e-6a8b-4cd8-bd0e-68890bee58182025-05-29WarningsExact identifier
unii: L7T10EIP3A
RockSauce Warming MassageMENTHOL, METHYL SALICYLATENantong Health & Beyond Hygienic Products Inc.b679ed7b-9d88-4eff-9743-567affe0fe2b2025-05-27WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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