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 118 of 132 · 2,630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sting-KillBENZOCAINE AND MENTHOLRANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTHb8bd9280-f20a-4b2a-aef7-a0ba7b3b87012023-12-29WarningsExact identifier
unii: L7T10EIP3A
Maybelline New York Baby Lips Dr Rescue Medicated BalmMENTHOLL'Oreal USA Products Inc2f7b8221-66f6-4aed-8359-318cfc656a722023-12-28WarningsExact identifier
unii: L7T10EIP3A
EXTERNAL ANALGESICCAMPHOR, CAPSICUM, MENTHOLHmong 213b6155a5-51aa-2780-e054-00144ff8d46c2023-12-26WarningsExact identifier
unii: L7T10EIP3A
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Witch HazelWITCH HAZELPharma Nobis, LLCe42f484d-a644-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
unii: 101I4J0U34
Dermoplast Pain relievingBENZOCAINE, MENTHOLAdvantice Healthdad00c95-4e11-3eec-e053-2a95a90a7a182023-12-21WarningsExact identifier
unii: L7T10EIP3A
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.0239ada0-644d-4ef4-a3b8-df70246a3bc22023-12-21WarningsExact identifier
unii: L7T10EIP3A
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.a698502d-c1c5-41ca-8142-74338b834c8b2023-12-21WarningsExact identifier
unii: L7T10EIP3A
Valtrum IMMEDIATE ACTION TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELABORATORIOS QUANTIUM LLCc4efa317-8dd1-49e1-b7ca-9df2147edd3e2023-12-21WarningsExact identifier
unii: L7T10EIP3A
NUMSTAT Antiseptic and Pain Relieving Prep PadALCOHOL, MENTHOL, AND BENZOCAINE PREP PADSpectra Medical Devices, LLC07d20040-9dd9-0aba-e063-6294a90ab7cf2023-12-20WarningsExact identifier
unii: L7T10EIP3A
Health Mart Witch HazelWITCH HAZELStrategic Sourcing Services LLC2a1d9b27-0bd4-4475-8218-ba0f5560a9692023-12-20WarningsExact identifier
unii: 101I4J0U34
CVS Cold and Hot Roll-OnCOOL AND HEAT PAIN RELIEFCVS Pharmacyb8cc578a-be6d-90c0-e053-2995a90a77422023-12-20WarningsExact identifier
unii: L7T10EIP3A
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
unii: 101I4J0U34
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
unii: 101I4J0U34
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONHumco Holding Group, Inca8bf9744-9979-13c1-e053-2a95a90a30aa2023-12-15WarningsExact identifier
unii: L7T10EIP3A
GNP Witch HazelWITCH HAZELAmerisource Bergen45ac839d-215d-4c5f-8ae5-5e111d1700612023-12-14WarningsExact identifier
unii: 101I4J0U34
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
Freds Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLDiscount Drug Mart8697b932-da5a-717e-e053-2a91aa0afcae2023-12-12WarningsExact identifier
unii: L7T10EIP3A
CVS Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLCVS86972218-31fe-6942-e053-2991aa0a88502023-12-12WarningsExact identifier
unii: L7T10EIP3A
Best Choice Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLvalue merchandisers869631f8-aa1e-8ea4-e053-2a91aa0a5c572023-12-12WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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