FDA.reportPublic FDA data

NDC 76348-583-02 - Restoriden Lidocaine 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
76348-583
Requested NDC
76348-583-02
Package NDCs from labels
76348-583-02, 76348-583-01
Manufacturer
RENU LABORATORIES, INC.
Effective date
2020-10-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Restoriden Lidocaine Pain Relief CreamRENU LABORATORIES, INC.2020-10-20HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-583-012022-01-28C16284748780-1d6a99b39-681a-a426-e053-dadaa90af4c2Restoriden Lidocaine Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-583-01Restoriden Lidocaine Cream1 in 1 BOXCREAM11
76348-583-02Restoriden Lidocaine Cream56 g in 1 JARCREAM561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-583RESTORIDEN LIDOCAINE CREAM (LIDOCAINE) CREAM [RENU LABORATORIES, INC.]1Legacy NDC, 2 package rows20201120_b20e8649-9459-a9cb-e053-2a95a90ab31c.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 25 of 62 · 1,236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidozall PlusLIDOCAINE HYDROCHLORIDEV2 Pharma LLCba3cbb15-f4ed-443e-af43-a758481acb0b2025-11-12WarningsExact identifier
rxcui: 1010895
unii: V13007Z41A
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
TopCare Pain Relief Maximum StrengthLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATESb0ae3a7c-52d1-4923-bd50-6bb3749006c82025-11-11WarningsExact identifier
unii: V13007Z41A
ComfortcaineLIDOCAINE HCLQS Key West Aloe, LLC831b7c11-e437-4e74-808e-c9c1eb8b82f62025-11-11WarningsExact identifier
unii: V13007Z41A
DermaNumb AnalgesicLIDOCAINE HCLA.T.S. Laboratories, LLC0ea46890-45c3-4732-bc47-227f7c67daf12025-11-11WarningsExact identifier
unii: V13007Z41A
Arnica AconitumARNICA ACONITUMUriel Pharmacy Inc.ba2a81b4-9efc-4706-9330-97475a27dc822025-11-11WarningsExact identifier
unii: OZ0E5Y15PZ
Derma Numb Pain ReliefLIDOCAINE HCLA.T.S. Laboratories, LLC710991ae-8f82-4893-93a7-0ef3f815d1322025-11-11WarningsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEEugia US LLC5524cbfd-d6e6-42eb-aaa5-22495e0a86b62025-11-11Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
unii: V13007Z41A
GuruNanda Pain ReliefLIDOCAINE HYDROCHLORIDEGuruNanda, LLC.3ab6a133-8dca-e14e-e063-6394a90a85e72025-11-10WarningsExact identifier
unii: V13007Z41A
Genuine First Aid Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.48867a79-4d21-4ba1-9cf9-7839352a4b7e2025-11-07WarningsExact identifier
unii: V13007Z41A
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Atti amour Rose Anti-Aging Repair Classic EssenceNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1e874ac0-a993-be9e-e063-6394a90af4242025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Eye CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eeb9c36-5bd8-ec90-e063-6294a90ae4e12025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair SerumNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eb08f86-eb2a-7f29-e063-6294a90a05162025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Moisturizing CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eec4cfe-d5a3-3570-e063-6294a90ac38b2025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Pain Relieving CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HCLTARGET CORPORATION944b3f78-3efa-484b-84f0-00ffe95c5dfb2025-11-05WarningsExact identifier
unii: V13007Z41A
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
unii: PDC6A3C0OX
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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