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 34 of 62 · 1,236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Westlake Outdoor Pain and Itch RelievingLIDOCAINE 4% PAIN AND ITCH RELIEVINGWESTLAKE HB PHARMA3c563b28-4f4f-9d0c-e063-6294a90adf732025-07-01WarningsExact identifier
rxcui: 1010895
unii: V13007Z41A
Arnica NettleARNICA NETTLEUriel Pharmacy Inc.d694f7c5-050a-1883-e053-2995a90afc792025-06-30WarningsExact identifier
unii: OZ0E5Y15PZ
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
unii: PDC6A3C0OX
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
MyDermLIDOCAINEInspec Solutions LLC.82d075d1-c92e-2097-e053-2991aa0ab1312025-06-18WarningsExact identifier
unii: V13007Z41A
Silicone Scar CreamDIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOINYunqi Cosmetics (Shenzhen) Co., Ltd37d02d8c-fbb5-5ba5-e063-6294a90a43ac2025-06-17WarningsExact identifier
unii: R0ZB2556P8
Curist 5% LidocaineLIDOCAINE 5%Little Pharma, Inc.f20241a2-c5b1-f124-e053-2995a90a891b2025-06-16WarningsExact identifier
unii: V13007Z41A
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst952ffcce-0ec4-61c9-e053-2995a90a84af2025-06-16Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Diabecin HRLIDOCAINE HCL, BENZALKONIUM CHLORIDEPureTek Corporation36c60fe2-5b7b-83dd-e063-6294a90ad4672025-06-10Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
RECOVERY NumbingLIDOCAINE HCLRenu Laboratories, LLCe4e05cae-56a6-b2b3-e053-2a95a90a104b2025-06-06WarningsExact identifier
unii: V13007Z41A
LidoGuardLIDOCAINE HCLViolaCare, Inc.531383aa-4f0f-4fe0-91f4-d809b39f160f2025-06-04WarningsExact identifier
rxcui: 1010895
unii: V13007Z41A
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.e0e621d2-10b0-4cdf-b31d-c19b1e86ba6b2025-06-03Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
BurnLIDOCAINE HYDROCHLORIDEJ&A Digital Inc.d4b09055-b93e-466f-9e24-cae098af6e242025-06-02WarningsExact identifier
unii: V13007Z41A
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Band Aid Antiseptic Cleansing LiquidBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEKenvue Brands LLCd2a6e0d2-5b9b-11c0-e053-2a95a90a4df02025-05-26WarningsExact identifier
unii: V13007Z41A
Bliss RepublicLIDOCAINE NUMBING EXTRA STRENGTH CREAMSargass Group Limited Liability Company35aba13a-95e6-a395-e063-6294a90a5bdc2025-05-21WarningsExact identifier
unii: V13007Z41A
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
unii: PDC6A3C0OX
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company35415851-beba-5bb4-e063-6294a90a35c02025-05-16WarningsExact identifier
unii: V13007Z41A
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c2025-05-16WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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