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 59 of 132 · 2,639 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
CONSTIPATIONMAGNESIA CARBONICA, MAGNESIA MURIATICA, AESCULUS HIPPOCASTANUM, ALUMEN, ALUMINA, BRYONIA ALBA, NUX VOMICA, SILICEANatural Creations, Inc.d2e24f5a-747b-4d62-bbdf-16c0e43becdb2025-11-21WarningsExact identifier
unii: 02F3473H9O
DG 4x Medicated Tooth and Gum CreamBENZOCAINEDollar Generalb2c156f0-6d11-1eba-e053-2995a90a6db82025-11-21WarningsExact identifier
unii: L7T10EIP3A
4x Medicated Toothache and Gum GelBENZOCAINECVSa7577d5f-69cf-3f32-e053-2995a90aaba52025-11-21WarningsExact identifier
unii: L7T10EIP3A
Toothache and Gum Relief CushionsBENZOCAINERite Aid9970d485-0b78-1438-e053-2995a90ad32c2025-11-21WarningsExact identifier
unii: L7T10EIP3A
Nighttime 4X Medicated CreamBENZOCAINERite Aid21645ed1-2dc0-223a-e063-6394a90ab0212025-11-21WarningsExact identifier
unii: L7T10EIP3A
4x Medicated Gum CreamBENZOCAINEAlbertsonsb81a308c-9c30-0e3d-e053-2a95a90a15d22025-11-21WarningsExact identifier
unii: L7T10EIP3A
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCb0edd9d9-951f-d3dd-e053-2995a90a8d5a2025-11-21WarningsExact identifier
unii: L7T10EIP3A
Throat Coat Eucalyptus MintMENTHOLTraditional Medicinals, Inc.a7a86f1b-30e8-6f5d-e053-2a95a90a2a822025-11-21WarningsExact identifier
unii: L7T10EIP3A
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.4538248f-11cc-d6b2-e063-6294a90a652c2025-11-21WarningsExact identifier
unii: L7T10EIP3A
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCf03090fa-f7e6-f53a-e053-2a95a90aa8192025-11-20WarningsExact identifier
unii: L7T10EIP3A
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INCff073e47-3107-e17e-e053-6294a90a58fa2025-11-20WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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