FDA.reportPublic FDA data

NDC 76348-950-03 - INSPIRATION ACADEMY MENTHOL COOLING ROLL ON

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
76348-950
Requested NDC
76348-950-03
Package NDCs from labels
76348-950-03, 76348-950-01
Manufacturer
RENU LABORATORIES, INC.
Effective date
2022-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Inspiration Academy Menthol Cooling Roll-OnRENU LABORATORIES, INC.2022-01-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-950-012025-01-30C16284748780-12cef2736-89e2-d83d-e063-dadaa90ab31fInspiration Academy Menthol Cooling Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-950-01INSPIRATION ACADEMY MENTHOL COOLING ROLL ON1 in 1 BOXLIQUID12
76348-950-03INSPIRATION ACADEMY MENTHOL COOLING ROLL ON84 g in 1 APPLICATORLIQUID842

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-950INSPIRATION ACADEMY MENTHOL COOLING ROLL ON (MENTHOL) LIQUID [RENU LABORATORIES, INC.]2Legacy NDC, 2 package rows20220115_ce169ac8-f942-daed-e053-2995a90aa743.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 176 of 184 · 3,669 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Concept DHAVITAMIN- MINERAL OMEGA-3 SUPPLEMENTU.S. Pharmaceutical Corporationbd2051f7-b887-46f6-8d4a-b099fcd086292022-11-08WarningsExact identifier
unii: DE08037SAB
Concept OBVITAMIN MINERAL SUPPLEMENTU.S. Pharmaceutical Corporation37992a25-68bd-4050-b936-596ddedc25a32022-11-08Warnings, Adverse reactionsExact identifier
unii: DE08037SAB
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
Dr Talbots Infant Pain Inflamtion ReliefARNICA 12X,BELLIS PERENNIS 12X,CALENDULA OFFICINALIS 12X,CHAMOMILLA 12X,COFFEA CRUDA 12X,HYPERICUM 12X,MILLEFOLIUM 12X,FERRUM PHOSPHORICUM 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 6XTalbots Pharmaceuticals Family Products, LLC.e892c0cb-03b4-52da-e053-2995a90a08782022-09-12WarningsExact identifier
unii: O80TY208ZW
LidotholLIDOCAINE HCL, MENTHOLAsclemed USA, Inc.6d7adaca-67dd-4a4b-a85c-d1c2a568dee22022-09-09Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
DEFENSE Hand SanitizerISOPROPYL ALCOHOLWalla Walla Environmental, Inc.af49488d-5aeb-e3d9-e053-2a95a90afb042022-08-31WarningsExact identifier
unii: ND2M416302
DEFENSE Hand SanitizerISOPROPYL ALCOHOLWalla Walla Environmental, Inc.af498f92-6029-46b9-e053-2995a90a1c6d2022-08-31WarningsExact identifier
unii: ND2M416302
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
unii: L7T10EIP3A
Magnesia MuriaticaMAGNESIA MURIATICAHahnemann Laboratories, INC.e45cf05f-7ca8-2654-e053-2a95a90a74252022-07-21Exact identifier
unii: 02F3473H9O
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: 6OZP39ZG8H
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEFresenius Kabi, USA, LLCeb360dc4-88d6-4b28-9b61-bc359e16bd222022-05-27Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O

Reported adverse events (FAERS/openFDA)#

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