FDA.reportPublic FDA data

NDC 76348-680-04 - op6 Menthol Cooling Pain Cream

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
76348-680
Requested NDC
76348-680-04
Package NDCs from labels
76348-680-04, 76348-680-01
Manufacturer
Renu Laboratories, Inc.
Effective date
2021-09-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
op6 Menthol Cooling Pain CreamRenu Laboratories, Inc.2021-09-10HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-680-012025-01-30C16284748780-12cef2736-7a7b-d83d-e063-dadaa90ab31fop6 Menthol Cooling Pain Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-680-01op6 Menthol Cooling Pain Cream1 in 1 BOXCREAM11
76348-680-04op6 Menthol Cooling Pain Cream112 g in 1 JARCREAM1121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-680OP6 MENTHOL COOLING PAIN CREAM (MENTHOL) CREAM [RENU LABORATORIES, INC.]1Legacy NDC, 2 package rows20210915_cbab043c-9711-1d30-e053-2a95a90aefb0.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 29 of 134 · 2,671 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
Eucalyptol, Menthol, Methyl Salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLStrategic Sourcing Services LLC03c7e7f3-f72d-49c8-96ca-1d7422413ab42026-02-17Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
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
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
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLValu Merchandisers Companyd0ff1845-b937-457d-a6f0-b0c875f12c812026-02-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Witch HazelWITCH HAZELValu Merchandisers Company7c6fa37f-79b8-4409-b7a9-3f02332f887a2026-02-16Warnings, Adverse reactionsExact identifier
unii: 101I4J0U34
Hemp Magic Fast-Acting Pain Relief CreamMENTHOLNexxus Capital LLC4af69640-1413-868b-e063-6394a90a39892026-02-16WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLUnited Natural Foods, Inc. dba UNFIcce74940-ebf1-4fa4-9ef4-50619704d5cd2026-02-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
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
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTopco Associates LLC62eed0e8-ba5f-45c2-a543-68b50bcf4b0c2026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Original AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLCb6c8d5b1-4b19-463c-826a-cccdcec09e2d2026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLC24b19a98-143d-4634-b2b3-4d02dfd579872026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLCa1915524-2719-40d4-86e3-35df5ce3238d2026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Witch HazelWITCH HAZELTopco Associates LLC471a9f8d-ba12-41d3-a510-20c1a13ff8502026-02-13Warnings, Adverse reactionsExact identifier
unii: 101I4J0U34
Gel Cooling Pain ReliefMENTHOLTopco Associates LLC80962394-a46f-48fd-8e0c-685dd1e500d72026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar control plus AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLC0d97cb54-1b9c-4aff-a15c-3bf9b66782092026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLC2022986a-2a93-4291-887c-c23f2b2c83a72026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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