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 39 of 132 · 2,639 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacy022c3083-c611-47d0-aa93-d6c7612e7a472026-01-11WarningsExact identifier
unii: L7T10EIP3A
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacybf73d15a-9d68-42fa-bfee-d25748215f972026-01-11WarningsExact identifier
unii: L7T10EIP3A
LubracaneLUBRACANEOzeion LLC7c503e3e-1987-4027-8a43-12acf2cb548a2026-01-10WarningsExact identifier
unii: L7T10EIP3A
Vascu-Pro T009CACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltd01d22fd6-7d2f-4448-81ff-c88baafc0af72026-01-09WarningsExact identifier
unii: 02F3473H9O
HyVee Throat Drops Lemon MintMENTHOLHY-VEE, INC47f738cc-7968-cc07-e063-6294a90af7ab2026-01-09WarningsExact identifier
unii: L7T10EIP3A
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-OnMENTHOLInspec Solutions12ff9b9a-73e5-ce31-e063-6294a90aeaf82026-01-09WarningsExact identifier
unii: L7T10EIP3A
HyVee Cough Drops Original HerbMENTHOLHY-VEE, INC47f81e54-0ce4-439d-e063-6294a90a2abe2026-01-09WarningsExact identifier
unii: L7T10EIP3A
2.5% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLCc842544a-6aea-42af-a77e-7b202371b3872026-01-09WarningsExact identifier
unii: L7T10EIP3A
4% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLC7fb95135-4151-4ef4-bb6d-75251cafff6c2026-01-09WarningsExact identifier
unii: L7T10EIP3A
E.O.L.STILLINGIA SYLVATICA, ZINCUM GLUCONICUM, THIAMINUM HYDROCHLORICUM, FRAGARIA VESCA, NICOTINAMIDUM, RHEUM (PALMATUM), SEROTONIN (HYDROCHLORIDE), 5-HYDROXYTRYPTOPHAN, BETAINUM MURIATICUM, BIOTIN, CHOLINUM, CYSTEINUM, DL-METHIONINE, L-ALANINE, L-CYSTINE, L-GLUTAMIC ACID, L-GLUTAMINE, L-LYSINE, L-METHIONINE, L-SERINE, PARA-AMINOBENZOIC ACID, POTASSIUM GLUCONATE, THYMUS (SUIS), THYROIDINUM (SUIS), UBIDECARENONUM, VITAMIN D3, DOPAMINE HYDROCHLORIDE, LITHIUM BROMATUM, SQUALENE, VACCINIUM MACROCARPON, OXYTOCIN,InLight Creation, LLC.b317d812-d6ed-4a2f-93f7-08b12261cc992026-01-09WarningsExact identifier
unii: Q9L0O73W7L
Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEMeijer Distribution, Inc781f89c0-94ab-48de-9e0b-decb37bcde462026-01-09WarningsExact identifier
unii: L7T10EIP3A
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 02F3473H9O
PAIN RELIEF Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd22d9ce20-1cb6-c5bd-e063-6394a90a9eca2026-01-08WarningsExact identifier
unii: L7T10EIP3A
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INT'L THERMO ANALGETICS ROLL-ON76ef713b-e23d-7b98-e053-2991aa0aad512026-01-08WarningsExact identifier
unii: L7T10EIP3A
Dentemp Canker CoverCANKER COVERDOC Brands2e7fbf9d-553c-c7bf-e063-6294a90a5f792026-01-08WarningsExact identifier
unii: L7T10EIP3A
HyVee Throat Drops Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.47e2650f-4f50-8d85-e063-6394a90a1ddc2026-01-08WarningsExact identifier
unii: L7T10EIP3A
Dentemp Canker CoverCANKER COVERDOC Brands2b4b22e9-a03b-fb8f-e063-6394a90a87472026-01-08WarningsExact identifier
unii: L7T10EIP3A
AER Traveler ToweletteAER TRAVELERBirchwood Laboratories LLC26556b9b-1c3a-6cf5-e063-6394a90ab26c2026-01-08WarningsExact identifier
unii: 101I4J0U34
HyVee Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.e4e15c13-f583-4484-a5f0-f04c39c7b7c92026-01-08WarningsExact identifier
unii: L7T10EIP3A
K2 Cold TherapyMENTHOLThe Podiatree Co60dce1ad-125e-396d-e053-2a91aa0a670f2026-01-08WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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