FDA.reportPublic FDA data

NDC 76348-615-03 - REMEDY Pain Relief Cooling Menthol 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
76348-615
Requested NDC
76348-615-03
Package NDCs from labels
76348-615-03, 76348-615-01
Manufacturer
RENU LABORATORIES, INC.
Effective date
2021-05-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
REMEDY COOLING MENTHOL ROLL ONRENU LABORATORIES, INC.2021-05-10HUMAN OTC DRUG LABEL

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 128 of 190 · 3,786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-119PLANTAGO MAJOR, DELPHINIUM STAPHISAGRIA SEED, MATRICARIA CHAMOMILLA, SEPIA OFFICINALIS JUICE, ARNICA MONTANA, HYPERICUM PERFORATUM, STRYCHNOS NUX-VOMICA SEED, SPIGELIA ANTHELMIA, IRON, BARIUM CARBONATE, VERATRUM ALBUM ROOT, CALCIUM FLUORIDE, ANTIPYRINE, AND BISMUTH SUBNITRATEDNA Labs, Inc.c9463aa1-ac37-42f9-bc2b-785e3d2befad2025-01-13WarningsExact identifier
unii: O80TY208ZW
D-110ARNICA MONTANA, HYPERICUM PERFORATUM, PHOSPHORUS, RANCID BEEF, RUTA GRAVEOLENS FLOWERING TOP, FERROSOFERRIC PHOSPHATE, LACHESIS MUTA VENOM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, AND CALENDULA OFFICINALIS FLOWERING TOPDNA Labs, Inc.780ec514-9e36-4a4c-b947-960888fa7c752025-01-13WarningsExact identifier
unii: O80TY208ZW
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
unii: ND2M416302
CalmoseptineANORECTAL OINTMENTCalmoseptine Inc.ff9539ed-d9ae-401d-adbc-df8f1d7514312025-01-13WarningsExact identifier
unii: L7T10EIP3A
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
unii: L7T10EIP3A
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact identifier
unii: ND2M416302
Kanka Triple ActionBENZOCAINE AND MENTHOL, UNSPECIFIED FORMBlistex Inc.078fcdab-38a1-4a9a-bdd3-e17446591ea82025-01-09WarningsExact identifier
unii: L7T10EIP3A
SinEcchARNICA MONTANAHahnemann Laboratories, Inc. dba Alpine Pharmaceuticals7c25c517-13ce-50e4-e053-2a91aa0af0172025-01-09Exact identifier
unii: O80TY208ZW
SINECCHiARNICA MONTANAHahnemann Laboratories Inc. dba Alpine Pharmaceuticals36ffb596-1c53-49e6-9228-5c2d378e11632025-01-09Exact identifier
unii: O80TY208ZW
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
unii: L7T10EIP3A
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

Reported adverse events (FAERS/openFDA)#

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