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 127 of 131 · 2,601 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot Pro DryCAMPHOR, MENTHOLChattem, Inc.4de1bc29-d166-4599-9e75-5f841bf209672023-03-01WarningsExact identifier
unii: L7T10EIP3A
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Purifying S.O.S spotgelLIMONENEinthismorning co ltdf3e7d6b6-9edf-5cbf-e053-2995a90a3e702023-02-04WarningsExact identifier
unii: GFD7C86Q1W
Purifying centella soothing maskLIMONENE, LINALOOLinthismorning co ltdf375209f-11d7-efb6-e053-2995a90a7e132023-01-30WarningsExact identifier
unii: GFD7C86Q1W
Purifying Balance Soothing Peeling PadLIMONENEinthismorning co ltdf3759715-6398-0305-e053-2995a90aa1002023-01-30WarningsExact identifier
unii: GFD7C86Q1W
Puritying Skin BalanceCreamHEXYL CINNAMAL, LIMONENEinthismorning co ltdf3743bc8-4747-4702-e053-2a95a90a08882023-01-29WarningsExact identifier
unii: GFD7C86Q1W
STOPAIN CLINICAL Migraine and HeadacheMENTHOL, UNSPECIFIED FORM, ATROPA BELLADONNA, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOTTroy Manufacturing, Inc.c5b690ce-7bb6-4840-b00b-205cd5bc6be62023-01-25WarningsExact identifier
unii: L7T10EIP3A
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
unii: L7T10EIP3A
DALEKTRO NSILVER NITRATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, COBALTOUS NITRATE HEXAHYDRATE, CUPRIC ACETATE, IRON, POTASSIUM CARBONATE, MAGNESIUM CHLORIDE, MANGANESE ACETATE TETRAHYDRATE, SELENIUM, SILICON DIOXIDE, AND ZINC PHOSPHIDEPEKANA Natruheilmittel GmbH2b39ce30-54ff-4586-bda1-d9410140b26e2023-01-11WarningsExact identifier
unii: 02F3473H9O
co-HYPERTSODIUM TETRACHLOROAURATE, BARIUM CARBONATE, ANAMIRTA COCCULUS SEED, IBERIS AMARA SEED, MAGNESIUM CHLORIDE, FERULA SUMBUL ROOT, MELILOTUS OFFICINALIS TOP, AND VISCUM ALBUM FRUITING TOPPEKANA Naturheilmittel Gmbh19ba62c0-2c49-47c4-9406-0e637df04b752023-01-11WarningsExact identifier
unii: 02F3473H9O
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Magnesia muriaticaMAGNESIUM CHLORIDEBoiron862f775e-3a62-ddc7-e053-2991aa0ac4aa2023-01-05Exact identifier
unii: 02F3473H9O
Multiple Electrolytes pH 7.4SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLC84221110-b3f1-42f4-800c-ad1d3b330e9e2022-11-10Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
Multiple Electrolytes pH 5.5SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLCcf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c2022-11-10Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Icy Hot Vanishing ScentMENTHOLChattem, Inc.e2092016-9741-433d-92e6-74bfddadb72c2022-09-29WarningsExact identifier
unii: L7T10EIP3A
Beol Cho LongMENTHOL, GARLIC OILsunkyung tradinge939d073-35b0-6a6d-e053-2995a90a0d182022-09-21WarningsExact identifier
unii: L7T10EIP3A
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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