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 160 of 190 · 3,785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Reliever CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.130665d6-3de8-cb91-e063-6294a90a20832024-03-06WarningsExact identifier
unii: L7T10EIP3A
Dermachange Cold TherapyMENTHOLPrivate Label Beauty and Wellness12ef7dd8-3da3-9c87-e063-6394a90ac9242024-03-05WarningsExact identifier
unii: L7T10EIP3A
Oral HealthBORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANSDeseret Biologicals, Inc.81ffb30f-5255-4e16-ba9d-b0de909aa5572024-03-05WarningsExact identifier
unii: 02F3473H9O
InflammationARNICA MONTANA, BENZOICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), APIS MELLIFICA, BAPTISIA TINCTORIA, DULCAMARA, EUCALYPTUS GLOBULUS, SOLANUM NIGRUM, EUPATORIUM PERFOLIATUM, BRYONIA (ALBA), COLCHICUM AUTUMNALE, MERCURIALIS PERENNIS, RHUS TOXDeseret Biologicals, Inc.98578714-8408-4bc0-82ff-faa88cda37572024-03-05WarningsExact identifier
unii: O80TY208ZW
PTS/Stress RemedyKALI PHOSPHORICUM, AMBRA GRISEA, CACAO, PHOSPHORICUM ACIDUM, ARNICA MONTANA, CALCAREA CARBONICA, CEREBRUM SUIS, GLANDULA SUPRARENALIS SUIS, LITHIUM CARBONICUM, ACONITUM NAPELLUS, ARGEMONE MEXICANA, ARSENICUM ALBUM, CICUTA VIROSA, HYOSCYAMUS NIGER, IGNATIA TIGRINUM, NATRUM MURIATICUM, TARENTULA HISPANICA, STRAMONIUM, BUTHUS AUSTRALISDeseret Biologicals, Inc.05341147-789a-4844-9412-6a3044e5eb182024-03-04WarningsExact identifier
unii: O80TY208ZW
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC3b1cfa8a-942f-471e-b7c0-744f83b687a02024-03-02WarningsExact identifier
unii: 101I4J0U34
AnalgesicMENTHOLSafetec of America, Inc.b0f4010c-995f-40e1-aa40-92760e697a612024-03-02WarningsExact identifier
unii: L7T10EIP3A
Arnica montanaARNICA MONTANANewton Laboratories, Inc.4b3153e1-1e75-7d05-e063-6394a90a066c2024-03-01WarningsExact identifier
unii: O80TY208ZW
Icy Hot Advanced ReliefCAMPHOR AND MENTHOLChattem, Inc.9979ff36-415b-44e4-bb10-6bf682cd00f92024-03-01WarningsExact identifier
unii: L7T10EIP3A
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLC5051b650-18a4-481e-a8d7-d41d4ae51efd2024-02-29WarningsExact identifier
unii: L7T10EIP3A
Amish Origins Pain Relieving Menthol 8MENTHOLAmish Origins Management, LLCaaad56d5-6737-4edc-af0e-8e207695c0ec2024-02-29WarningsExact identifier
unii: L7T10EIP3A
Rite Aid Swimmers Ear DropsISOPROPYL ALCOHOLRite Aid12875b9d-3ae8-bd0c-e063-6294a90ab4ae2024-02-29WarningsExact identifier
unii: ND2M416302
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLCb120404f-5a07-4182-bb50-d943418622da2024-02-29WarningsExact identifier
unii: L7T10EIP3A
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEAdvanced Rx Pharmacy of Tennessee, LLC128d0ba9-bc9d-af16-e063-6394a90af5ef2024-02-29WarningsExact identifier
unii: L7T10EIP3A
Immune SupportECHINACEA (ANGUSTIFOLIA), ARNICA MONTANA, BAPTISIA TINCTORIA, SANGUINARIA CANADENSIS, ARISTOLOCHIA CLEMATITIS, EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINARUM, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, MERCURIUS CORROSIVUS, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), RHUS TOX, SULPHUR, THUJA OCCIDENTALIS, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, ZINCUM METALLICUM, ASTRAGALUS MEMBRANACEUS, INFLUENZINUM (2022-2023), SPLEEN (SUIS), THYMUS,Deseret Biologicals, Inc.55e12503-4782-424a-8661-6107aa9838e22024-02-29WarningsExact identifier
unii: O80TY208ZW
Leader Roll-On Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERe86cba40-6b10-454d-98b3-6b547456eaad2024-02-29WarningsExact identifier
unii: L7T10EIP3A
XtraCare Vaporizing Chest RubCAMPHOR, MENTHOLRejoice Internationalc3e220d6-fff4-452f-99a9-bd701fc608a02024-02-28WarningsExact identifier
unii: L7T10EIP3A
meijer Cold Therapy Pain Relieving analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Incfb163112-d84d-418d-a410-3214c0ee4b5a2024-02-28WarningsExact identifier
unii: L7T10EIP3A
EPST PLUSCARDUUS MARIANUS, CISTUS CANADENSIS, DULCAMARA, GALIUM APARINE, MAGNESIA MURIATICA, NATRUM SULPHURICUM, VISCUM ALBUM, MURIATICUM ACIDUM, FOLLICULINUM, AQUA MARINA, AILANTHUS GLANDULOSUS, BARYTA MURIATICA, CADMIUM METALLICUM, CEANOTHUS AMERICANUS, COCCULUS INDICUS, IRIDIUM METALLICUM, THUJA OCCIDENTALIS, CINCHONA OFFICINALIS, CALCAREA CARBONICA, CROTALUS CASCAVELLADeseret Biologicals, Inc.c2bb50a8-e4f9-4af4-aefc-53c9c3cfcc252024-02-27WarningsExact identifier
unii: 02F3473H9O
BORR PLUSARNICA MONTANA, ECHINACEA (ANGUSTIFOLIA), TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, KALMIA LATIFOLIA, LEDUM PALUSTRE, GUNPOWDER, ADRENALINUM, THYROIDINUM (SUIS), ARBUTUS ANDRACHNE, ARSENICUM ALBUM, COCCULUS INDICUS, LAC CANINUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RHUS TOX, TELLURIUM METALLICUMDeseret Biologicals, Inc.2ee85443-5f1f-4da1-98f7-479630c165c12024-02-27WarningsExact identifier
unii: O80TY208ZW

Reported adverse events (FAERS/openFDA)#

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