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 156 of 190 · 3,785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidoReal PatchLIDOCAINE AND MENTHOLFORREAL PHARMACEUTICALS LLC19f1c037-b4b8-47b0-b0f9-036691c1d3072024-07-05WarningsExact identifier
unii: L7T10EIP3A
Severe Throat DropsMENTHOL ICETarget Corporation Inc.1876b221-fa60-5269-e063-6394a90a69632024-07-04WarningsExact identifier
unii: L7T10EIP3A
Quality ChoiceISOPROPYL ALCOHOLChain Drug Marketing Association Inc1262c5d7-63ef-f1c1-e063-6294a90a1f0f2024-07-02WarningsExact identifier
unii: ND2M416302
MenopauseAGNUS CASTUS, ANGELICA SINENSIS RADIX, APIS MELLIFICA, ARALIA QUINQUEFOLIA, ARNICA MONTANA, CIMICIFUGA RACEMOSA, GALIUM APARINE, GLYCYRRHIZA GLABRA, OOPHORINUM SUIS, SEPIA, THUJA OCCIDENTALIS, VISCUM ALBUMLiddell Laboratories, Inc.3e17fa78-f5c2-47eb-9bb6-075ccffd01b62024-07-01WarningsExact identifier
unii: O80TY208ZW
Lip Medex Lip BalmPETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.988f97e8-a59f-4bc0-9d71-60607364a6862024-07-01WarningsExact identifier
unii: L7T10EIP3A
VITAL IIARNICA MONTANA, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HYPOPHYSIS SUIS, PANAX GINSENG, L-ARGININE, OLEUM ANIMALE, SCHISANDRA CHINENSIS, TARAXACUM OFFICINALE, THUJA OCCIDENTALISLiddell Laboratories, Inc.04cded9a-0431-4e87-9055-ec4f381125592024-07-01WarningsExact identifier
unii: O80TY208ZW
EMFARGENTUM NITRICUM, ARNICA MONTANA, BAPTISIA TINCTORIA, CINCHONA OFFICINALIS, GALIUM APARINE, HEPAR SUIS, NATRUM CARBONICUM, PANAX GINSENG, PHOSPHORICUM ACIDUM, PHOSPHORUS, RHODODENDRON CHRYSANTHUM, STRONTIUM CARBONICUM, SULPHUR IODATUM, THUJA OCCIDENTALIS, X-RAYLiddell Laboratories, Inc.3fa1b8d3-7c09-431b-b843-03b2ef8a92b12024-07-01WarningsExact identifier
unii: O80TY208ZW
Back Pain and SciaticaACONITUM NAPELLUS, ARNICA MONTANA, BELLADONNA, CIMICIFUGA RACEMOSA, EUPHORBIUM OFFICINARUM, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOXLiddell Laboratories, Inc.2ae11146-b869-4a53-afa3-805de12921f92024-07-01WarningsExact identifier
unii: O80TY208ZW
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALMMENTHOLL'Oreal USA Products Incd580982f-dda6-4b03-bf84-342b9f2c6d932024-06-29WarningsExact identifier
unii: L7T10EIP3A
Lip Medex CherryPETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORMBlistex Inc.fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af82024-06-28WarningsExact identifier
unii: L7T10EIP3A
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bd5cf69-9a08-5e2e-e063-6394a90a03cd2024-06-26WarningsExact identifier
unii: L7T10EIP3A
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production(Xiamen) Co.,Ltdd8842561-f61e-4cac-80d6-001e5369f0d12024-06-25WarningsExact identifier
unii: ND2M416302
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bc1bf83-91ee-ec9d-e063-6394a90a3daf2024-06-25WarningsExact identifier
unii: L7T10EIP3A
Halls MentholyptusMENTHOLMondelez Global LLCf5292c5b-5608-4e13-afc2-4f3d7133da882024-06-25WarningsExact identifier
unii: L7T10EIP3A
Halls StrawberryMENTHOLMondelez Global LLC75638f29-7f2a-46b0-b8a0-e87bc7d6eba12024-06-25WarningsExact identifier
unii: L7T10EIP3A
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1bc2f688-d0c4-690e-e063-6294a90abc382024-06-25WarningsExact identifier
unii: L7T10EIP3A
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1b9fdac0-9fb0-e669-e063-6394a90aece92024-06-24WarningsExact identifier
unii: L7T10EIP3A
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
Halls StrawberryMENTHOLMondelez Global LLCde401eb4-3282-4298-8a51-15d2682534642024-06-21WarningsExact identifier
unii: L7T10EIP3A
Medicated BodyMENTHOL AND ZINC OXIDEUniversal Distribution Center LLC2a59a847-cc7a-42cf-b49a-92e7254c16292024-06-19WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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