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 36 of 62 · 1,236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lignospan ForteLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.f8ca7d03-01c8-450f-9279-59789c3497ea2025-03-20Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.037764d3-da0e-5ebb-e063-6294a90ab6e02025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
XeroBurn Burn GelLIDOCAINE HYDROCHLORIDEDynarex Corporation58985046-ca9c-12be-e053-2991aa0abe722025-03-13WarningsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENovagenix Labs LLC7567ffb5-953a-4be9-9a02-c5a50dcd93062025-03-12Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDEARMAS PHARMACEUTICALS INC.2f6e0f3d-ceaf-a853-e063-6394a90a8efb2025-03-07Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: PDC6A3C0OX
Redicare Burn GelREDICARE BURN GELRedicare LLC947ac362-acfb-3508-e053-2a95a90a28732025-03-05WarningsExact identifier
unii: V13007Z41A
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
unii: V13007Z41A
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: PDC6A3C0OX
4% lidocaine plus 1% menthol Pain Relief PatchPAIN RELIEF PATCH, PAIN RELIEF STRIPXuzhou Lanting Pharmaceutical Co., Ltd2f98ee5e-e4eb-fbda-e063-6394a90a709c2025-03-01WarningsExact identifier
unii: V13007Z41A
4% Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHXuzhou Lanting Pharmaceutical Co., Ltd2f98a6e9-b7c4-061e-e063-6294a90a67282025-03-01WarningsExact identifier
unii: V13007Z41A
Arthcal Estriol Face Cream for WomenSHEA BUTTER,TOCOPHEROL,ESTRIOLBeijing JUNGE Technology Co., Ltd.2f2f71c2-763d-0290-e063-6394a90a72ca2025-02-28WarningsExact identifier
unii: R0ZB2556P8
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
unii: PDC6A3C0OX
Lightning Products BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.555ac696-e761-4a5a-bed8-945dc64d5be52025-02-27WarningsExact identifier
unii: V13007Z41A
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
unii: PDC6A3C0OX
Arnica 30ARNCIA 30Uriel Pharmacy, Inc2eade2a6-a5d6-24a9-e063-6394a90a30ea2025-02-21WarningsExact identifier
unii: OZ0E5Y15PZ
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEPreferred Pharmaceuticals Inc.c259ef92-5d07-4590-adf1-3a106333eee02025-02-21WarningsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCf1b26274-a55e-4321-b96c-ce0df830f2052025-02-20Warnings, Adverse reactionsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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