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 74 of 131 · 2,618 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLMY IMPORTS USA LLC3cde0c23-5c5c-9715-e063-6294a90a94622025-08-21WarningsExact identifier
unii: L7T10EIP3A
Dermedial Anti-OuchMENTHOLNatures Formulae Health Products Ltd.3ce29160-3964-e435-e063-6394a90abb382025-08-21WarningsExact identifier
unii: L7T10EIP3A
Barrier Protectant CreamBARRIER CREAMCardinal Health539d9aac-75cf-4efd-bb3e-b465563304ca2025-08-21WarningsExact identifier
unii: L7T10EIP3A
SUGARLOAF ORGANICS MENTHOL REVIVEMENTHOLRENU LABORATORIES, LLCfa2f9539-b703-a00b-e053-6394a90ae3092025-08-21WarningsExact identifier
unii: L7T10EIP3A
Camphor 4% Plus Menthol 10%CAMPHOR 4% PLUS MENTHOL 10%PureTek Corporation3cab26e4-e377-f26a-e063-6394a90a17af2025-08-20WarningsExact identifier
unii: L7T10EIP3A
MedPride Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLShield Line LLC85cd2fb8-d688-c3a3-e053-2991aa0ac18c2025-08-20WarningsExact identifier
unii: L7T10EIP3A
Game OnMENTHOL, METHYL SALICYLATENatural Essentials, Inc.3cd20f1f-033f-f698-e063-6294a90a89eb2025-08-20WarningsExact identifier
unii: L7T10EIP3A
Fast Freeze Pain RelievingMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.15a26af1-ca5a-40fc-a411-6c0e8ae18fbb2025-08-18WarningsExact identifier
unii: L7T10EIP3A
Norms HemorrhoidPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZELTotally Normal Company3c98cc12-2476-9f73-e063-6394a90a6f232025-08-17WarningsExact identifier
unii: 101I4J0U34
Earth Mama Medicated Herbal Lip BalmMENTHOLEleeo Brands LLC3c6c16bb-1f4b-b851-e063-6294a90a74042025-08-15WarningsExact identifier
unii: L7T10EIP3A
MedPride Cold Ice Analgesic GelMENTHOLSHIELD LINE LLC860a2c86-b240-4e0e-e053-2a91aa0a333a2025-08-15WarningsExact identifier
unii: L7T10EIP3A
MedPride Medicated Body Powder PowderMENTHOL, ZINC OXIDEShield Line LLCcdb2fa5b-cf04-c876-e053-2a95a90a187c2025-08-15WarningsExact identifier
unii: L7T10EIP3A
SmoflipidSMOFLIPIDFresenius Kabi USA, LLCe0e9d917-ff6f-488e-a6a8-0ad59dd17d802025-08-15Warnings, Adverse reactionsExact identifier
unii: 6UYK2W1W1E
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.40df30ba-41ba-42b7-93fe-4183b57bdb002025-08-14WarningsExact identifier
unii: L7T10EIP3A
MGC Health Drops Sugar Free Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.b9227966-847c-40c3-87f2-8bea3954ec842025-08-12WarningsExact identifier
unii: L7T10EIP3A
Exchange Select Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fbece335-a7e5-4732-a086-561b237415792025-08-12WarningsExact identifier
unii: L7T10EIP3A
Exchange Select Drops Sugar Free Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.5f4b1960-43ac-4c74-9410-210c48bd8a1b2025-08-12WarningsExact identifier
unii: L7T10EIP3A
MGC Health Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.779ddb89-b6e2-4bfb-bcb5-8c7ec916675a2025-08-12WarningsExact identifier
unii: L7T10EIP3A
Fast FreezeMENTHOLNatural Essentials Inc.d8c42c8d-6ce0-43bf-b165-41979f3d8f792025-08-12WarningsExact identifier
unii: L7T10EIP3A
Dermedial Anti-OuchMENTHOLSaje Natural Business Inc.3c194b8f-cfa5-11e3-e063-6394a90a92de2025-08-11WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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