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 147 of 190 · 3,785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SpinaparAESCULUS HIPPOCASTANUM, HARPAGOPHYTUM, PHYTOLACCA DECANDRA, RUTA GRAVEOLENS, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, AGARICUS MUSCARIUS, ARGENTUM METALLICUM, ARNICA MONTANA, BAMBUSA ARUNDINACEA, BELLIS PERENNIS, BRYONIA (ALBA), CALCAREA FLUORICA, HYPERICUM PERFORATUM, RHUS TOX, SULPHUR, TELLURIUM METALLICUMEnergique, Inc.e3e1da2e-965b-4be7-a43d-a6cef46922482024-10-30WarningsExact identifier
unii: O80TY208ZW
Granulotion MedicatedMENTHOL, ZINC OXIDEGL HEALTH, INC.01701780-b160-415b-b34d-3622371794752024-10-29WarningsExact identifier
unii: L7T10EIP3A
HealthWise Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcare25a19d3e-37b3-50d5-e063-6394a90a97d12024-10-29WarningsExact identifier
unii: L7T10EIP3A
Menthol Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.Le82dac83-2910-44dc-e053-2995a90a38e12024-10-29WarningsExact identifier
unii: L7T10EIP3A
TheraCare Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcared6e789c7-a55a-dc9a-e053-2a95a90a2bdb2024-10-29WarningsExact identifier
unii: L7T10EIP3A
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.38fd4f98-a42a-435b-9643-16df664539512024-10-29WarningsExact identifier
unii: 02F3473H9O
Numbness HPACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ARNICA MONTANA, COFFEA CRUDA, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, PHOSPHORUS, PLUMBUM METALLICUMEnergique, Inc.0c4ba547-b4b4-41d0-8a6b-1141ff5f94532024-10-29WarningsExact identifier
unii: O80TY208ZW
NeuroparPASSIFLORA INCARNATA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (BOVINE), ARANEA DIADEMA, ARNICA MONTANA, ARSENICUM ALBUM, HYPERICUM PERFORATUM, LACHESIS MUTUS, PHYSOSTIGMA VENENOSUM, ZINCUM PICRICUMEnergique, Inc.76fc7c3d-c001-4ba0-821b-7d8544f6670b2024-10-29WarningsExact identifier
unii: O80TY208ZW
Pre/Post SurgetoneHYPERICUM PERFORATUM, RHUS TOX, STAPHYSAGRIA, SYMPHYTUM OFFICINALE, ARNICA MONTANA, PHOSPHORUS, CALENDULA OFFICINALISEnergique, Inc.8cbe3be1-e50c-4ad9-ab15-c696059f03a22024-10-29WarningsExact identifier
unii: O80TY208ZW
Premier Value Fiber TherapyMETHYLCELLULOSEPHARMACY VALUE ALLIANCE, LLCb875d5f8-02f3-4474-9fda-83091bc7de042024-10-28WarningsExact identifier
unii: MRJ667KA5E
Rael PAIN RELIEF ROLL-ON AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMRael, Inc.e6c49606-7c13-4dc6-a22d-ba54173ba7882024-10-28WarningsExact identifier
unii: L7T10EIP3A
ChloraspeticMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.2b1808b2-2574-4ab8-a762-5733251848ce2024-10-25WarningsExact identifier
unii: L7T10EIP3A
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLAsclemed USA, Inc.1553351c-aee8-4c40-9548-35cce246bda92024-10-25WarningsExact identifier
unii: L7T10EIP3A
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.d500f423-b9f2-4d98-8f2a-8bab7c05737c2024-10-25WarningsExact identifier
unii: L7T10EIP3A
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.b30e4b32-89dd-4e53-81d5-1415105361d42024-10-25WarningsExact identifier
unii: L7T10EIP3A
CirculaparCACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSEnergique, Inc.5bc2bcd0-5687-462a-8701-37c904a2e2d02024-10-24WarningsExact identifier
unii: 02F3473H9O
unii: O80TY208ZW
ElimitoneBELLIS PERENNIS, ECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ARNICA MONTANA, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUMEnergique, Inc.bc6352e0-6851-4971-948b-b18da7c1c8b62024-10-24WarningsExact identifier
unii: O80TY208ZW
ArnicaARNICA MONTANAEnergique, Inc.1a09f009-7178-44d1-abf4-5704ae16f99e2024-10-24WarningsExact identifier
unii: O80TY208ZW
ArnicaARNICA MONTANAEnergique, Inc.616e40d9-b1f0-4d17-b739-b548785cb34b2024-10-24WarningsExact identifier
unii: O80TY208ZW
Care and Comfort CreamACONITUM NAPELLUS, ARNICA MONTANA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, COLOCYNTHIS, HYPERICUM PERFORATUM, PULSATILLA (PRATENSIS), RHUS TOX, SYMPHYTUM OFFICINALEEnergique, Inc.ac8ee81f-0af4-46d4-b63f-beeb7d120f802024-10-24WarningsExact identifier
unii: O80TY208ZW

Reported adverse events (FAERS/openFDA)#

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