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 39 of 134 · 2,671 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LONAZEMMENTHOL,PETROLATUMPEER PHARM LTD.91f7a741-4178-4639-9cd5-746a4b9a21bf2026-01-12WarningsExact identifier
unii: L7T10EIP3A
Witch HazelWITCH HAZELHydrox Laboratories73391eb3-c17c-4104-93b1-2decfb2ebdf92026-01-12WarningsExact identifier
unii: 101I4J0U34
Witch HazelWITCH HAZELDealMed Medical Supplies LLCa8eaa516-f830-410a-9f75-fa54903956cd2026-01-12WarningsExact identifier
unii: 101I4J0U34
Mineral Ice Pain RelievingMENTHOLCrown Laboratories7b30076a-0af6-2f74-e053-2a91aa0ae08d2026-01-12WarningsExact identifier
unii: L7T10EIP3A
SarnaPRAMOXINE HYDROCHLORIDE, MENTHOLCrown Laboratories, Inc19c41e75-a654-90cf-e063-6394a90a7e972026-01-12WarningsExact identifier
unii: L7T10EIP3A
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf1efb51c-5217-4cb2-e053-2a95a90a7f952026-01-12WarningsExact identifier
unii: L7T10EIP3A
Hemorrhoidal Hygiene padsWITCH HAZELAkron Pharma Inc.936a0cca-5049-4ddf-9581-75c2da6d9cfa2026-01-12WarningsExact identifier
unii: 101I4J0U34
Extra Strength BalmCAPSICUM AND MENTHOLSaje Natural Business Incf516e416-446b-8f21-e053-2a95a90afd882026-01-12WarningsExact identifier
unii: L7T10EIP3A
Pain ReleaseMENTHOLSaje Natural Business Inc.3df0e56a-7651-42dc-8ed8-f68836a63c612026-01-12WarningsExact identifier
unii: L7T10EIP3A
Trauma LessMENTHOLSaje Natural Business Inc.650cba4c-6aba-48c3-9c41-841f199055482026-01-12WarningsExact identifier
unii: L7T10EIP3A
Chest ComfortMENTHOLSaje Natural Business Inc.8a3db169-6dd7-4dfd-8360-90315288f21b2026-01-12WarningsExact identifier
unii: L7T10EIP3A
MamisanLIDOCAINE HYDROCHLORIDE, MENTHOLMiramar Cosmetics, Inc DBA Miramar Lab4402e900-c6e9-4f32-8cc4-c84014384a9f2026-01-12WarningsExact identifier
unii: L7T10EIP3A
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacy022c3083-c611-47d0-aa93-d6c7612e7a472026-01-11WarningsExact identifier
unii: L7T10EIP3A
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacybf73d15a-9d68-42fa-bfee-d25748215f972026-01-11WarningsExact identifier
unii: L7T10EIP3A
LubracaneLUBRACANEOzeion LLC7c503e3e-1987-4027-8a43-12acf2cb548a2026-01-10WarningsExact identifier
unii: L7T10EIP3A
Vascu-Pro T009CACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltd01d22fd6-7d2f-4448-81ff-c88baafc0af72026-01-09WarningsExact identifier
unii: 02F3473H9O
HyVee Throat Drops Lemon MintMENTHOLHY-VEE, INC47f738cc-7968-cc07-e063-6294a90af7ab2026-01-09WarningsExact identifier
unii: L7T10EIP3A
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-OnMENTHOLInspec Solutions12ff9b9a-73e5-ce31-e063-6294a90aeaf82026-01-09WarningsExact identifier
unii: L7T10EIP3A
HyVee Cough Drops Original HerbMENTHOLHY-VEE, INC47f81e54-0ce4-439d-e063-6294a90a2abe2026-01-09WarningsExact identifier
unii: L7T10EIP3A
2.5% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLCc842544a-6aea-42af-a77e-7b202371b3872026-01-09WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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