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 40 of 134 · 2,671 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLC7fb95135-4151-4ef4-bb6d-75251cafff6c2026-01-09WarningsExact identifier
unii: L7T10EIP3A
E.O.L.STILLINGIA SYLVATICA, ZINCUM GLUCONICUM, THIAMINUM HYDROCHLORICUM, FRAGARIA VESCA, NICOTINAMIDUM, RHEUM (PALMATUM), SEROTONIN (HYDROCHLORIDE), 5-HYDROXYTRYPTOPHAN, BETAINUM MURIATICUM, BIOTIN, CHOLINUM, CYSTEINUM, DL-METHIONINE, L-ALANINE, L-CYSTINE, L-GLUTAMIC ACID, L-GLUTAMINE, L-LYSINE, L-METHIONINE, L-SERINE, PARA-AMINOBENZOIC ACID, POTASSIUM GLUCONATE, THYMUS (SUIS), THYROIDINUM (SUIS), UBIDECARENONUM, VITAMIN D3, DOPAMINE HYDROCHLORIDE, LITHIUM BROMATUM, SQUALENE, VACCINIUM MACROCARPON, OXYTOCIN,InLight Creation, LLC.b317d812-d6ed-4a2f-93f7-08b12261cc992026-01-09WarningsExact identifier
unii: Q9L0O73W7L
Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEMeijer Distribution, Inc781f89c0-94ab-48de-9e0b-decb37bcde462026-01-09WarningsExact identifier
unii: L7T10EIP3A
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 02F3473H9O
PAIN RELIEF Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd22d9ce20-1cb6-c5bd-e063-6394a90a9eca2026-01-08WarningsExact identifier
unii: L7T10EIP3A
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INT'L THERMO ANALGETICS ROLL-ON76ef713b-e23d-7b98-e053-2991aa0aad512026-01-08WarningsExact identifier
unii: L7T10EIP3A
Dentemp Canker CoverCANKER COVERDOC Brands2e7fbf9d-553c-c7bf-e063-6294a90a5f792026-01-08WarningsExact identifier
unii: L7T10EIP3A
HyVee Throat Drops Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.47e2650f-4f50-8d85-e063-6394a90a1ddc2026-01-08WarningsExact identifier
unii: L7T10EIP3A
Dentemp Canker CoverCANKER COVERDOC Brands2b4b22e9-a03b-fb8f-e063-6394a90a87472026-01-08WarningsExact identifier
unii: L7T10EIP3A
AER Traveler ToweletteAER TRAVELERBirchwood Laboratories LLC26556b9b-1c3a-6cf5-e063-6394a90ab26c2026-01-08WarningsExact identifier
unii: 101I4J0U34
HyVee Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.e4e15c13-f583-4484-a5f0-f04c39c7b7c92026-01-08WarningsExact identifier
unii: L7T10EIP3A
K2 Cold TherapyMENTHOLThe Podiatree Co60dce1ad-125e-396d-e053-2a91aa0a670f2026-01-08WarningsExact identifier
unii: L7T10EIP3A
4x Medicated Toothache and Gum CreamBENZOCAINEHEBa71c5259-cbcf-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
unii: L7T10EIP3A
3x Medicated Mouth Sore GelBENZOCAINEHEBa71c5259-cbd1-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
unii: L7T10EIP3A
4x Medicated Toothache and Gum GelBENZOCAINEPublix Super Markets INC16eb9d15-dba3-36e6-e063-6394a90ab8592026-01-08WarningsExact identifier
unii: L7T10EIP3A
Witch HazelWITCH HAZELEpic Medical Supply Corp.04ea35ab-9700-47a8-be77-1ada0eecc8412026-01-08WarningsExact identifier
unii: 101I4J0U34
Toothache and Gum ReliefBENZOCAINE, MENTHOLCVS Pharmacy814ec7bf-f825-1095-e053-2a91aa0aee592026-01-08WarningsExact identifier
unii: L7T10EIP3A
DZUL ARTHRITIS PAIN RELIEFMENTHOLCaball Sales, Inc.159c301c-d462-bb2c-e063-6394a90a9e5a2026-01-08WarningsExact identifier
unii: L7T10EIP3A
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
unii: L7T10EIP3A
Witch HazelWITCH HAZELArcadia Beauty Labs LLCe5100bd9-4a73-4593-af20-846e318905a02026-01-08WarningsExact identifier
unii: 101I4J0U34

Reported adverse events (FAERS/openFDA)#

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