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 129 of 131 · 2,601 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ConstipationABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUMNewton Laboratories, Inc.90804a94-1e67-3ab3-e053-2a95a90aafbe2020-11-24WarningsExact identifier
unii: 02F3473H9O
ab1f9eb0-eb52-48d3-e053-2995a90afe34aae3c43a-3839-01ce-e053-2a95a90a885c2020-07-23WarningsExact identifier
spl id: ab1f9eb0-eb52-48d3-e053-2995a90afe34
spl set id: aae3c43a-3839-01ce-e053-2a95a90a885c
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
CardioplegicCALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Corporation1fd50ce5-2799-4c26-81da-02cf0578dd9e2020-06-11Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
Dextrose and Electrolyte No. 48SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Companyb283a454-0c20-4fbf-92d3-dae1f3cd3cad2020-02-13Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plasma-Lyte ASODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEBaxter Healthcare Corporation6ec9e61c-2c26-402f-8604-f446b2e340582019-08-05Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
Fire OutBENZOCAINE AND MENTHOLRandob Ltd.77ab634e-13d4-4f5f-87c8-73976e65a8422019-04-12WarningsExact identifier
unii: L7T10EIP3A
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.c7cdbf2f-4841-4a7a-9056-6a741abc31332019-01-19WarningsExact identifier
unii: L7T10EIP3A
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.b8f0c61e-83b0-4835-b950-2c5dcce5cf172019-01-19WarningsExact identifier
unii: L7T10EIP3A
MEDICATED LIP BALMMENTHOL AND EUCALYPTUSBurt's Bees, Inc.30da3cc5-6140-2dee-e054-00144ff8d46c2018-12-21WarningsExact identifier
unii: L7T10EIP3A
GUNA-ORALACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL -Guna spaf1b8e5ab-8689-4bf2-a6d9-863d02f295792018-12-21WarningsExact identifier
unii: 101I4J0U34
Instaflex Pain Relief CreamMENTHOLAdaptive Health, LLC911f5021-a851-444e-8c2a-2be4fa94e8282018-12-21WarningsExact identifier
unii: L7T10EIP3A
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Fast FreezeCAMPHOR (NATURAL), MENTHOLNatural Essentials Inc.60c94da8-6c00-4544-a9a6-a3e87ebabd682018-10-18WarningsExact identifier
unii: L7T10EIP3A
AnalgesicMENTHOLSafetec of America, Inc.a90266d4-1e71-4805-aeca-6f8ed45135bb2018-10-01WarningsExact identifier
unii: L7T10EIP3A
COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEFMENTHOLNATURAL ESSENTIALS, INC.9fcc79e6-8176-4ebc-8602-0649b02fab862018-09-27WarningsExact identifier
unii: L7T10EIP3A
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Pure-AidCAMPHOR, MENTHOL, METHYL SALICYLATEKareway Product, Inc.6def9da7-e118-fd5c-e053-2991aa0a65d22018-06-05WarningsExact identifier
unii: L7T10EIP3A
SoundbodyLIDOCAINE, MENTHOLKareway Product, Inc.6c83ec36-3e3d-07a9-e053-2a91aa0ac54c2018-05-18WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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