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 159 of 190 · 3,785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relieving LinimentCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.97a0c839-0927-4e54-aee2-ded2016ac4a02024-04-02WarningsExact identifier
unii: L7T10EIP3A
Isopropyl Alcohol Cleansing Pad TOALLITAS HUMEDAS CON ALCOHOL ISOPROPILICOISOPROPYL ALCOHOLM-star (Hubei) Health&Care Products Co., Ltd.42a482ab-2a62-4c39-8ea5-5e57ef794b8f2024-04-01WarningsExact identifier
unii: ND2M416302
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
Oral HealthANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,Deseret Biologicals, Inc.6f66ff40-6e0e-4a35-963c-965c65df76eb2024-04-01WarningsExact identifier
unii: 02F3473H9O
Arnica Gel 15 Arnica Montana 1X HPUSARNICA GELVITAMEDICA, INC.4e56ff37-e260-be18-e063-6294a90aaced2024-03-31WarningsExact identifier
unii: O80TY208ZW
Heart/FatigueKALI CARBONICUM, ARNICA MONTANA, CACTUS GRANDIFLORUS, CASTOREUM, RANUNCULUS BULBOSUS, GELSEMIUM SEMPERVIRENS, GLONOINUM, HEART (SUIS), SPIGELIA ANTHELMIA, ABROTANUM, SULPHURDeseret Biologicals, Inc.560c2269-2cc8-489e-8487-9661ff7017d82024-03-27WarningsExact identifier
unii: O80TY208ZW
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
Bug Bites - Itch StopperPYROGENIUM, APIS MEL., ARANEA DIADEMA, ARNICA, ARSENICUM ALB., AZADIRACHTA INDICA, BRYONIA, CALADIUM SEGUINUM, CALENDULA, FORMICA, GRINDELIA, HYPERICUM, LACHESIS, LATRODECTUS MACTANS, LEDUM, MEZEREUM, NUX VOM., PULEX IRRITANS, RHUS TOXICODENDRON, TARENTULA CUBENSIS, TARENTULA HISPANA, THERIDION, THUJA OCC., VESPA CRABRO, ECHINACEA, HAMAMELIS, SOLIDAGONewton Laboratories, Inc.14453db1-05f6-db38-e063-6294a90ae3012024-03-22WarningsExact identifier
unii: O80TY208ZW
I.V. Prep Antiseptic WipeISOPROPYL ALCOHOLSmith & Nephew, Medical Ltd50f1c74a-bb8e-41c2-a7ee-f2d310a372a72024-03-21WarningsExact identifier
unii: ND2M416302
SucretsDYCLONINE HCL, MENTHOL, AND PECTINInsight Pharmaceuticals LLC2a2839ea-11d3-4390-930d-0da912a9c6f52024-03-20WarningsExact identifier
unii: L7T10EIP3A
ARNICA MONTANAARNICA MONTANARxhomeo Private Limited d.b.a. Rxhomeo, Inc14018b2a-6862-35cf-e063-6394a90a5cf62024-03-19WarningsExact identifier
unii: O80TY208ZW
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC6bec225e-a203-4866-b0db-b76f73a6ae252024-03-19WarningsExact identifier
unii: L7T10EIP3A
Isopropyl AlcoholISOPROPYL ALCOHOLProvision Medicalad045374-f4ad-4003-b350-8a2b0cbccb2e2024-03-14WarningsExact identifier
unii: ND2M416302
Rugby Ice Blue External AnalgesicMENTHOL, UNSPECIFIED FORMRugby Laboratories2b65cb6a-4364-4770-b7b9-5c4637edd01a2024-03-14WarningsExact identifier
unii: L7T10EIP3A
Leader Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERfd06d17f-4dff-42a9-a84f-904809ceb9812024-03-13WarningsExact identifier
unii: L7T10EIP3A
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
MENTHOL, CAMPHORMENTHOL, CAMPHOREROS GLOBALb3495c95-ba4b-9459-e053-2a95a90a710f2024-03-12WarningsExact identifier
unii: L7T10EIP3A
HerXECHINACEA (ANGUSTIFOLIA), ARNICA MONTANA, HYDRASTIS CANADENSIS, LEDUM PALUSTRE, MAGNESIA SULPHURICA, KALMIA LATIFOLIA, ARSENICUM ALBUM, COCCULUS INDICUS, PHOSPHORUSDeseret Biologicals, Incae270bbf-40c8-44e9-91ea-ee5ddbdd9f542024-03-11WarningsExact identifier
unii: O80TY208ZW
ImmunogesicARNICA MONTANA, APIS MELLIFICA, BENZOICUM ACIDUM, CARTILAGO SUIS, LEDUM PALUSTRE, PANTOTHENIC ACID, RUTA GRAVEOLENS, RHODODENDRON CHRYSANTHUM, CAUSTICUM, FORMICA RUFA, SEPIA, ALPHA-LIPOICUM ACIDUM, AURUM METALLICUM, CALCAREA PHOSPHORICA, COLCHICUM AUTUMNALE, PHYTOLACCA DECANDRA, RADIUM BROMATUM, RHUS VENENATA, THUJA OCCIDENTALIS, LAC CANINUMDeseret Biologicals, Inc.a7363a92-bcef-450e-9168-39f51a57cf3e2024-03-07WarningsExact identifier
unii: O80TY208ZW
Trauma RemedyCHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, MILLEFOLIUM, CALENDULA OFFICINALIS, ARNICA MONTANA, BELLIS PERENNIS, RHUS TOX, BRYONIA (ALBA), CLEMATIS VITALBA, FOLIA, HEPAR SULPHURIS CALCAREUM, ORNITHOGALUM UMBELLATUM, PRUNUS CERASIFERA, FLOS, CARBO VEGETABILISDeseret Biologicals, Inc.d8610c75-2d98-4810-8265-96f8f151b61f2024-03-07WarningsExact identifier
unii: O80TY208ZW

Reported adverse events (FAERS/openFDA)#

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