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 85 of 132 · 2,639 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zpol ULTRAMENTHOL, METHYL SALICYLATELaboratorios Zepol S.A.1a1433a6-8d04-96df-e063-6394a90a987b2025-03-27WarningsExact identifier
unii: L7T10EIP3A
LidotholLIDOCAINE HCL, MENTHOLClinic Pharma3159db23-6439-7c2e-e063-6294a90a310b2025-03-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.87ebb4d9-78d7-1c87-e053-2a95a90adb7d2025-03-27WarningsExact identifier
unii: L7T10EIP3A
Parche LeonCAPSAICIN, CAMPHOR, MENTHOLPharmadel LLCa8f266fa-6e43-559e-e053-2995a90a2c752025-03-26WarningsExact identifier
unii: L7T10EIP3A
HealthWise Lidocaine Plus Menthol PatchLIDOCAINE AND MENTHOLVeridian Healthcare312f15fe-9297-2dc2-e063-6294a90a6f4d2025-03-25WarningsExact identifier
unii: L7T10EIP3A
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHAdvanced Rx of Tennessee, LLC30c97646-db06-df84-e063-6394a90a77432025-03-20WarningsExact identifier
unii: L7T10EIP3A
Halls Sugar Free Black CherryMENTHOLMondelez Global LLCbd2a311a-bf0c-4365-af9b-76675c243b222025-03-16WarningsExact identifier
unii: L7T10EIP3A
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTARGET CORPORATIONfbca9627-5e12-048a-e053-6294a90a6e0f2025-03-15WarningsExact identifier
unii: L7T10EIP3A
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLDOLGENCORP, INC.0655688e-7c42-507f-e063-6294a90ae4982025-03-15WarningsExact identifier
unii: L7T10EIP3A
Salonpas Pain ReliefMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.acd7ba91-221a-485a-ad1f-dd41ed1556562025-03-14WarningsExact identifier
unii: L7T10EIP3A
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limited1ee49cad-84d4-42cf-aa83-c0da6f1b1b842025-03-14WarningsExact identifier
unii: L7T10EIP3A
Bestmade Natural Products Restful Legs SupportCALCAREA PHOSPHORICA, ACONITE NAP, ANACARDIUM ORI, ARGENTUM NIT, ARSENIC ALB, AURUM MUR, CHAMOMILLA, DUBOISIA, GELSEMIUM, IGNATIA, KALI BROM, LACHESIS MUTUS, LYCOPODIUM, MAG MUR, MOSCHUS, NAT CARB, NAT SULPH, PHOSPHORIC ACID, RAUWOLFIA SERPBestmade Natural Products304b48ac-c4b8-a5c0-e063-6394a90a07b62025-03-14WarningsExact identifier
unii: 02F3473H9O
AY BENDITO THERMOACTIVEMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC304d71b6-91c8-b2b6-e063-6394a90ab6692025-03-14WarningsExact identifier
unii: L7T10EIP3A
Hot/Cold Medicated PatchHOT COLD PATCHDynarex999881b3-287e-d975-e053-2995a90a87e32025-03-14WarningsExact identifier
unii: L7T10EIP3A
Dr Talbots Cooling Perineal PadWATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATETalbot's Pharmaceuticals family Products, LLC.242277e2-ff26-ad4e-e063-6394a90ab3172025-03-14WarningsExact identifier
unii: 101I4J0U34
Salonpas Pain ReliefMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.724bc4d3-0bc1-4275-a23b-4bbc62fbc0d22025-03-14WarningsExact identifier
unii: L7T10EIP3A
Salonpas Arthritis PainMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.2e88c933-89e6-4a48-be7a-dc6a36e5c8f82025-03-14WarningsExact identifier
unii: L7T10EIP3A
Peppermint Soothing PatchCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORMHenan Lijitang Medical Technology Co., Ltd.30361dd4-1f3d-ac5e-e063-6294a90a23bc2025-03-13WarningsExact identifier
unii: L7T10EIP3A
Arthcal VULVA BALMBEESWAX,SHEA BUTTER,GRAPE SEEDBeijing JUNGE Technology Co., Ltd.2f305967-207b-6da9-e063-6294a90a571c2025-03-11WarningsExact identifier
unii: K49155WL9Y
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d413707-794c-2fa8-e063-6394a90a06bf2025-03-11WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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