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 58 of 131 · 2,618 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meicated WipeWITCH HAZELDiamond Wipes International, Inc4458c80c-d013-55ba-e063-6394a90a6b392025-11-24WarningsExact identifier
unii: 101I4J0U34
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLATLANTIC BIOLOGICALS CORP.71a80e13-bda3-40fb-b4e7-45e9985e707c2025-11-24WarningsExact identifier
unii: L7T10EIP3A
Stopain Migraine Pain RelievingMENTHOLUM, BELLADONNA, IRIS VERSICOLOR, SANGUINARIA CANADENSISTROY MANUFACTURING, INC5641c17f-bf3f-48a5-a3a8-c80d381c17a42025-11-24WarningsExact identifier
unii: L7T10EIP3A
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDERVALU MERCHANDISERS, CO89a5c4bb-442f-d3f0-e053-2a95a90a51bd2025-11-24WarningsExact identifier
unii: L7T10EIP3A
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d11ab8e-d3ea-c7ef-e063-6294a90ae0a32025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d113dec-8832-d984-e063-6394a90ae7b32025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d12f03f-dd8b-0be5-e063-6294a90a43db2025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d129641-eaea-c3ee-e063-6394a90aa58f2025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.002db658-6b1f-ea49-e063-6294a90ae3e72025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.002997d0-3176-3918-e063-6294a90a44082025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d1059cc-1b0b-4e7b-e063-6294a90a56ea2025-11-24WarningsExact identifier
unii: L7T10EIP3A
GuruNanda Pain ReliefMENTHOL AND CAMPHORGURUNANDA, LLC3ca78342-cc6d-5f6b-e063-6294a90a3f1c2025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d118256-90ee-28ef-e063-6394a90a21e82025-11-24WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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