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 41 of 194 · 3,878 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucalyptol, Menthol, Methyl Salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLStrategic Sourcing Services LLC454065e4-5ccf-4c01-861b-8f0ca2cd23b62026-02-17Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: RV6J6604TK
Eucalyptol, Menthol, Methyl Salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLStrategic Sourcing Services LLC03c7e7f3-f72d-49c8-96ca-1d7422413ab42026-02-17Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: RV6J6604TK
Tylenol Precise Cooling Pain RelievingLIDOCAINE, MENTHOLKenvue Brands LLCfc0a3404-b174-3952-e053-6294a90a1e022026-02-16WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLValu Merchandisers Company117b44ba-5313-40f6-97c4-035a7f039fae2026-02-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: RV6J6604TK
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLValu Merchandisers Companyb6144732-99da-4be2-88e0-75f31b323d382026-02-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLValu Merchandisers Company93992f56-2e13-40d8-8e27-1f3989dd4c632026-02-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: RV6J6604TK
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLValu Merchandisers Companyd0ff1845-b937-457d-a6f0-b0c875f12c812026-02-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: RV6J6604TK
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLValu Merchandisers Companybe57aa83-f097-4ff8-81f8-13d731eea4e62026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Witch HazelWITCH HAZELValu Merchandisers Company7c6fa37f-79b8-4409-b7a9-3f02332f887a2026-02-16Warnings, Adverse reactionsExact identifier
unii: 101I4J0U34
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Company81b5a92a-27a9-41d2-bc88-920833be66382026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Hemp Magic Fast-Acting Pain Relief CreamMENTHOLNexxus Capital LLC4af69640-1413-868b-e063-6394a90a39892026-02-16WarningsExact identifier
unii: L7T10EIP3A
VoiceCalmARNICA MONTANA WHOLE, ARISAEMA TRIPHYLLUM ROOT, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, TOXICODENDRON PUBESCENS LEAF, SPONGIA OFFICINALIS SKELETON, ROASTEDBoiron4af6bc5b-7924-cb9f-e063-6394a90a78642026-02-16WarningsExact identifier
unii: O80TY208ZW
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLUnited Natural Foods, Inc. dba UNFIcce74940-ebf1-4fa4-9ef4-50619704d5cd2026-02-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: RV6J6604TK
ThroatCalmARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, BROMINE, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoiron4ae45fc7-c0f4-3770-e063-6394a90ac80e2026-02-15WarningsExact identifier
unii: O80TY208ZW
EUGENIA JAMBOSAARNICA MONTANA, BAPTISIA, ECHINACEA, EUGENIA JAMBOSA, HEPAR SHULPHBM Private Limited3b3c63cf-9a75-5a59-e063-6294a90a62d12026-02-15WarningsExact identifier
unii: O80TY208ZW
KALMIAARNICA MONTANA, CHELIDONIUM, COLCHICUM, KALMIA, RANUNCULUS BULB, SANGUINARIA NIT, SUMBULBM Private Limited3b3c955d-453e-28e2-e063-6394a90a6bf92026-02-15WarningsExact identifier
unii: O80TY208ZW
blue goo Pain RelievingMENTHOL 2.5%Garcoa, Inc.7b9b5ac6-9568-464c-8096-0302a1e650df2026-02-13WarningsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLTopco Associates LLCa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a2026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: RV6J6604TK
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTopco Associates LLC62eed0e8-ba5f-45c2-a543-68b50bcf4b0c2026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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