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 127 of 132 · 2,624 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: 4ELV7Z65AP
unii: 230OU9XXE4
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: GFD7C86Q1W
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: Z95S6G8201
unii: 059QF0KO0R
unii: E4F12ROE70
unii: HIE492ZZ3T
unii: 2DMT128M1S
unii: GFD7C86Q1W
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
unii: HIE492ZZ3T
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: GFD7C86Q1W
U ICE COLDMENTHOLUNIVERSAL DISTRIBUTION CENTER LLC752ef0cd-f12a-3b9e-e053-2991aa0abeb12023-09-01WarningsExact identifier
unii: L7T10EIP3A
LM Plus ReliefLIDOCAINE AND MENTHOLARI BRANDS, LLCe9b52074-b4ca-43e9-9f2e-2afcdb5efdc72023-09-01Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
MEB Gluco-Vitality PatchMEB GLUCO-VITALITY PATCHKadesh Incoporation Co,Ltd00daa9e5-c82a-c272-e063-6294a90ab5a92023-08-18WarningsExact identifier
unii: 02F3473H9O
Hepaticol SarcodeCARDUUS MARIANUS, ZINGIBER OFFICINALE, BERBERIS VULGARIS, CHELIDONIUM MAJUS, MAGNESIA MURIATICA, LEPTANDRA VIRGINICA, NATRUM MURIATICUM, BRYONIA (ALBA), HEPAR (BOVINE), NATRUM SULPHURICUM, ATROPINUM SULPHURICUM, LYCOPODIUM CLAVATUMNutritional Specialties, Inc.f9d95b2f-53d9-4017-873f-5ad0b129f9f82023-08-14WarningsExact identifier
unii: 02F3473H9O
MEB Puri-MegaMEB PURI-MEGAKadesh Incoporation Co,Ltd018125f2-ad4b-b38a-e063-6294a90a7f6e2023-07-27WarningsExact identifier
unii: 02F3473H9O
GenstatAESCULUS HIPPOCASTANUM, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, HYDROCOTYLE ASIATICA, OLEUM OLEA EUROPAEA, PASSIFLORA INCARNATA, RIBES NIGRUM, SOLIDAGO VIRGAUREA, ONONIS SPINOSAEnergique, Inc.492f311e-f4b5-442d-adc3-d022e58b185e2023-07-12WarningsExact identifier
unii: 6UYK2W1W1E
MentholatumMETHYL SALICYLATE, DL-MENTHOLLydia Co., Ltd.e9db590f-b19a-3fe8-e053-2995a90a4e742023-07-06WarningsExact identifier
unii: L7T10EIP3A
AMULDY SPORTS gelMENTHOL, METHYL SALICYLATE, CAMPHOR, SALICYLIC ACIDLydia Co., Ltd.a3fecbe6-4150-5d1e-e053-2995a90a974b2023-07-06WarningsExact identifier
unii: L7T10EIP3A
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DERLADIE MICELLAR CLEANSING WATER WITCH HAZELWITCH HAZELLAON COMMERCE co ltdfa607ee5-2a8d-567d-e053-6294a90ab5952023-04-27WarningsExact identifier
unii: 101I4J0U34
Theraworx Relief for Foot Cramps FoamMAGNESIUM SULFATE, UNSPECIFIED FORMAVADIM HOLDINGS, INC.2f7fe6b7-deb0-4bf7-a8cb-15ae468512da2023-04-25WarningsExact identifier
unii: DE08037SAB
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ATO TellMENTHOL, GARLIC OILsunkyung tradingf8b5525c-b4bf-d2ee-e053-6394a90a61c52023-04-06WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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