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 182 of 184 · 3,669 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA-REACTANGELICA SINENSIS ROOT - ARNICA MONTANA - ASIAN GINSENG - ECHINACEA ANGUSTIFOLIA - FOMITOPSIS PINICOLA FRUITING BODY - INTERFERON GAMMA-1B - PAEONIA OFFICINALIS ROOT - PORK LIVER - REISHI - SILYBUM MARIANUM SEED - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - TURMERIC -Guna spac2b64907-1ae2-4686-b13c-847dbb84724e2018-12-21WarningsExact identifier
unii: O80TY208ZW
GUNA-HEMORRHOIDSACTIVATED CHARCOAL - ARNICA MONTANA - ATROPA BELLADONNA - CANAKINUMAB - HYDROCOTYLE ASIATICA EXTRACT - AESCULUS HIPPOCASTANUM FLOWER - MELISSA OFFICINALIS - PAEONIA OFFICINALIS ROOT - PODOPHYLLUM PELTATUM ROOT - PORK LIVER - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa0fd0dcef-79c6-4489-a533-996aa5331d9c2018-12-21WarningsExact identifier
unii: O80TY208ZW
GUNA-ORALACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL -Guna spaf1b8e5ab-8689-4bf2-a6d9-863d02f295792018-12-21WarningsExact identifier
unii: 101I4J0U34
unii: O80TY208ZW
Instaflex Pain Relief CreamMENTHOLAdaptive Health, LLC911f5021-a851-444e-8c2a-2be4fa94e8282018-12-21WarningsExact identifier
unii: L7T10EIP3A
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
ArnicaARNICA MONTANAEnergique, Inc.96259b60-cd7f-40d9-a3d4-6a41a6e04f1e2018-10-24WarningsExact identifier
unii: O80TY208ZW
Fast FreezeCAMPHOR (NATURAL), MENTHOLNatural Essentials Inc.60c94da8-6c00-4544-a9a6-a3e87ebabd682018-10-18WarningsExact identifier
unii: L7T10EIP3A
AnalgesicMENTHOLSafetec of America, Inc.a90266d4-1e71-4805-aeca-6f8ed45135bb2018-10-01WarningsExact identifier
unii: L7T10EIP3A
COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEFMENTHOLNATURAL ESSENTIALS, INC.9fcc79e6-8176-4ebc-8602-0649b02fab862018-09-27WarningsExact identifier
unii: L7T10EIP3A
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: OJ245FE5EU
Pure-AidCAMPHOR, MENTHOL, METHYL SALICYLATEKareway Product, Inc.6def9da7-e118-fd5c-e053-2991aa0a65d22018-06-05WarningsExact identifier
unii: L7T10EIP3A
Free RadicalTRITICUM AESTIVUM, ALFALFA, FUCUS VESICULOSUS, LAMINARIA DIGITATA, NASTURTIUM AQUATICUM, ORYZA SATIVA, RAPHANUS SATIVUS, SYMPHYTUM OFFICINALE, HORDEUM VULGARE, ASPARAGUS OFFICINALIS, MANGANESE GLUCONATE, FERRUM PHOSPHORICUM, ARNICA MONTANA, CUPRUM METALLICUM, UBIDECARENONUM, ALPHA-KETOGLUTARICUM ACIDUM, GLYOXAL TRIMER DIHYDRATE, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUMBioActive Nutritional, Inc.e09f8fbb-e8c7-4c1b-994a-60f8fef79c0a2018-05-22WarningsExact identifier
unii: O80TY208ZW
SoundbodyLIDOCAINE, MENTHOLKareway Product, Inc.6c83ec36-3e3d-07a9-e053-2a91aa0ac54c2018-05-18WarningsExact identifier
unii: L7T10EIP3A
G7 FlexARNICA MONTANA, CARDUUS MARIANUS, HEPAR SUIS, HYPOPHYSIS SUIS, PANAX GINSENG, PHOSPHORICUM ACIDUMSafe Anabolic Sciencesde2d95b7-edca-41cd-9fd3-a98c124756d82018-05-04WarningsExact identifier
unii: O80TY208ZW
Avedana Cool Hot IceMENTHOLUnipack, Inc.619c8e3f-0cad-4eb1-8dbb-632f3db74ba32018-05-01WarningsExact identifier
unii: L7T10EIP3A
Pure-AidLIDOCAINE, MENTHOLKareway Product, Inc.6679cada-f083-26e8-e053-2a91aa0adcc52018-03-02WarningsExact identifier
unii: L7T10EIP3A
Arnica RecoveryARNICA MONTANANARTEX LABORATORIOS HOMEOPATICOS SA DE CVe9e22991-48a0-4e66-bd6f-267f3e8badd62018-02-27WarningsExact identifier
unii: O80TY208ZW
Trauma plus GelCALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUMEnergique, Inc.6da04ff9-4088-427c-9757-36092c8f75852018-02-08WarningsExact identifier
unii: O80TY208ZW
H-Arthritis FormulaAPIUM GRAVEOLENS, ARNICA MONTANAHealing Natural Oils LLC1db33e48-f37a-4d80-95b8-6574903dbc402017-12-27WarningsExact identifier
unii: O80TY208ZW

Reported adverse events (FAERS/openFDA)#

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