FDA.reportPublic FDA data

NDC 76348-660-03 - OP 6 MENTHOL WARMING 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
76348-660
Requested NDC
76348-660-03
Package NDCs from labels
76348-660-03, 76348-660-01
Manufacturer
RENU LABORATORIES, INC.
Effective date
2021-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OP 6 MENTHOL WARMING ROLL ONRENU LABORATORIES, INC.2021-08-11HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-660-012025-01-30C16284748780-12cef2736-aafb-d83d-e063-dadaa90ab31fOP 6 MENTHOL WARMING ROLL ON

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-660-01OP 6 MENTHOL WARMING ROLL ON1 in 1 BOXLIQUID11
76348-660-03OP 6 MENTHOL WARMING ROLL ON84 g in 1 APPLICATORLIQUID841

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-660OP 6 MENTHOL WARMING ROLL ON (MENTHOL) LIQUID [RENU LABORATORIES, INC.]1Legacy NDC, 2 package rows20210817_c94fd093-a09d-f4e8-e053-2995a90ad861.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 129 of 190 · 3,795 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Drs. pharmacy HEMORRHOIDAL COOLINGPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACYd6f6b482-d85d-001c-e053-2995a90ad98c2025-01-09WarningsExact identifier
unii: 101I4J0U34
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
unii: L7T10EIP3A
AM-11ARNICA MONTANA, SODIUM CHLORIDE, AND APIS MELLIFERADNA Labs, Inc.c072811b-6259-4b22-b364-50369dc68fb02025-01-09WarningsExact identifier
unii: O80TY208ZW
N-1 Adrenal EnergizerBERBERIS VULGARIS WHOLE, VISCUM ALBUM WHOLE, SOLIDAGO VIRGAUREA WHOLE, BOS TAURUS ADRENAL GLAND, ARNICA MONTANA, DIBASIC POTASSIUM PHOSPHATE, AND SUS SCROFA SPLEENDNA Labs, Inc.1bc8f7c1-76c2-457b-9e8d-9841ed531fc72025-01-09WarningsExact identifier
unii: O80TY208ZW
N-2SELENICEREUS GRANDIFLORUS WHOLE, CRATAEGUS LAEVIGATA WHOLE, DIBASIC POTASSIUM PHOSPHATE, ARNICA MONTANA, VALERIANA OFFICINALIS WHOLE, SPIGELIA ANTHELMIA, AND BEEF HEARTDNA Labs, Inc.29e3bc19-e3b6-4337-b8df-13b8b8b8da9f2025-01-09WarningsExact identifier
unii: O80TY208ZW
N-26BARIUM CHLORIDE DIHYDRATE, CONIUM MACULATUM WHOLE, ARNICA MONTANA, PHOSPHORIC ACID, DIBASIC POTASSIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, AND PORK BRAINDNA Labs, Inc.3fb35088-9c43-411f-992f-43b88ff239152025-01-09WarningsExact identifier
unii: O80TY208ZW
N-27ARNICA MONTANA, MILK THISTLE, SUS SCROFA CEREBRUM, CINCHONA OFFICINALIS BARK, GINKGO BILOBA WHOLE, LECITHIN, SOYBEAN, LITHIUM CARBONATE, ACHILLEA MILLEFOLIUM, PHOSPHORIC ACID, PORK BRAIN, ALNUS GLUTINOSA WHOLE, AND ROSMARINUS OFFICINALIS FLOWERING TOPDNA Labs, Inc.df2d7683-3b45-4ddb-9b67-7bb74dad28542025-01-09WarningsExact identifier
unii: O80TY208ZW
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
unii: L7T10EIP3A
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
unii: L7T10EIP3A
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
unii: L7T10EIP3A
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
unii: L7T10EIP3A
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
unii: AV092KU4JH
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 1VPU26JZZ4
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEGERI-GENTLE CORPORATIONe673d8bd-2573-9f04-e053-2995a90a172a2025-01-06WarningsExact identifier
unii: L7T10EIP3A
Venoforce IAESCULUS HIPPOCASTANUM, COLLINSONIA CANADENSIS, ECHINACEA (ANGUSTIFOLIA), HAMAMELIS VIRGINIANA, PULSATILLA (VULGARIS), ARNICA MONTANA, CARBO VEGETABILIS, GRAPHITES, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PAEONIA OFFICINALIS, SEPIA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.588233cb-fad0-4e65-97e9-9a419e07daab2025-01-06WarningsExact identifier
unii: O80TY208ZW

Reported adverse events (FAERS/openFDA)#

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