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 9 of 132 · 2,639 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VARICOSE VEINS MAXIMUM STRENGTHMENTHOLOWELL NATURAL & LLC5692914f-1b14-e3e3-e063-6394a90a94bf2026-07-14WarningsExact identifier
unii: L7T10EIP3A
SanatosMENTHOLPharmadel LLC5683b099-f029-2d08-e063-6394a90ad4822026-07-13WarningsExact identifier
unii: L7T10EIP3A
Propolis Cooling Relief Cherry Cough DropsMENTHOL, UNSPECIFIED FORMBeekeeper's Naturals USA Inc7087566d-f24a-4508-aa25-7f42d055c43e2026-07-13WarningsExact identifier
unii: L7T10EIP3A
Topcare Pain Relief PatchPAIN RELIEF PATCH MEDICATED 5% MENTHOL761624f00d0b8-d2f4-843b-e063-6294a90a332b2026-07-12WarningsExact identifier
unii: L7T10EIP3A
COUGH DROPS- menthol granuleMENTHOL GRANULEAnhui Jiuhe Health Industry Co., Ltd5351b943-5830-e4e7-e063-6394a90a5b662026-07-10WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ProfessionalMENTHOLReckitt Benckiser LLC485c8208-c93b-5b84-e063-6394a90ab77a2026-07-10WarningsExact identifier
unii: L7T10EIP3A
Fit Mist Pain ReliefMENTHOLAroma Sensations Incf5a98544-8bd7-42dc-a594-5559e3920e292026-07-09WarningsExact identifier
unii: L7T10EIP3A
Nuturna SciaticaMENTHOLMicelle Laboratories, Incorporatedff200864-bedf-4138-bdec-2b23701406dd2026-07-09WarningsExact identifier
unii: L7T10EIP3A
Nervionix Pro Magnesium IceLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporatedc11e0963-90fb-48c6-938a-3dcbbad17aca2026-07-09WarningsExact identifier
unii: 02F3473H9O
unii: L7T10EIP3A
CAREALL Musle and JointMENTHOLNew World Imports, Inc561cc103-ae88-8f30-e063-6294a90a05c42026-07-08WarningsExact identifier
unii: L7T10EIP3A
HealthWise Medicated Cold HotMENTHOLVeridian Healthcare, LLC561e1409-d1d8-e35d-e063-6394a90a4d8f2026-07-08WarningsExact identifier
unii: L7T10EIP3A
Natures Willow Balm Roll On Pain ReliefMENTHOLWB Ventures LLC3b1834e6-75cd-5380-e063-6294a90ad1d52026-07-08WarningsExact identifier
unii: L7T10EIP3A
Natures Willow Balm Itch Relief CreamMENTHOLWB Ventures LLC0ce31b5d-4401-460c-e063-6394a90ab5582026-07-08WarningsExact identifier
unii: L7T10EIP3A
Natures Willow BalmMENTHOLWB VENTURES LLCb9f50c43-b0d5-39a8-e053-2995a90a04f12026-07-08WarningsExact identifier
unii: L7T10EIP3A
Natures Willow Bug Bite BalmMENTHOLWB Ventures LLCb9fab18f-32c7-d5bd-e053-2995a90a6d0f2026-07-08WarningsExact identifier
unii: L7T10EIP3A
Salonpas pain relieving hotCAPSAICIN, MENTHOLHisamitsu Pharmaceutical Co., Inc.d2aa8820-a947-404b-b617-e692fbd165022026-07-07WarningsExact identifier
unii: L7T10EIP3A
Witch HazelWITCH HAZELH E B09b814f4-86b5-4810-bf52-cc88396451c22026-07-07Warnings, Adverse reactionsExact identifier
unii: 101I4J0U34
CrysaloMETHYL SALICYLATE, MENTHOLV2 Pharma, LLCd6c475f0-1098-41cd-868a-a5e528a5e5ae2026-07-06WarningsExact identifier
unii: L7T10EIP3A
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
unii: 2DMT128M1S
unii: 230OU9XXE4
unii: YD01N1999R
Mineral Ice Methol Pain ReliefMENTHOL 10.5 %Sunflora Inc6ddd9e97-f717-4d5a-9658-26449a3cc8312026-07-02WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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