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 42 of 62 · 1,229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Lidocaine 4 PercentLIDOCAINESA3, LLC651710db-3c50-4bcf-b7cc-9ed24f6634272024-12-09WarningsExact identifier
rxcui: 1010895
unii: V13007Z41A
AUVON Pain Relief Roll-onLIDOCAINESHENZHEN YUWEN E-COMMERCE CO., LTD.8b30f623-6077-4f2e-8fa4-ce4a298953b52024-12-08WarningsExact identifier
unii: V13007Z41A
QC Lidocaine Maximum StrengthLIDOCAINE HCLChain Drug Marketing Associationb5e1b1ab-8a95-2d2d-e053-2995a90aea532024-12-08WarningsExact identifier
rxcui: 1010895
unii: V13007Z41A
PO First Aid Series BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.f1c349a8-216d-4233-922e-c95329a33d1e2024-12-05WarningsExact identifier
unii: V13007Z41A
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
unii: V13007Z41A
Burts Bees Rapid Rescue Cold Sore TreatmentCAMPHOR, GLYCERINBurts Bees9f89735d-205f-4d3e-a1e1-ecc96284fe982024-12-03WarningsExact identifier
unii: PDC6A3C0OX
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
unii: V13007Z41A
BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENINGBO TIANBO FIRST AID PRODUCT CO., LTD.2ec1cf79-c341-4b79-9047-ce29f0dff4192024-11-29WarningsExact identifier
unii: V13007Z41A
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare242204d3-efc7-f7a9-e063-6294a90a5af12024-11-27WarningsExact identifier
rxcui: 1010895
unii: V13007Z41A
Lidotral Five Percent with MentholLIDOCAINE HYDROCHLORIDE, MENTHOLPureTek Corporation06ff69f7-1ded-b5c8-e063-6394a90a300f2024-11-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
unii: 6DC9Q167V3
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATEWestminster Pharmaceuticals, LLC0cd1394d-e7b2-4e60-87ac-e12a0bda9d672024-11-21Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Signature Care Lidocaine CreamLIDOCAINEBetter Living Brands LLC5483729e-ef1a-47a2-b7cf-c19744f520732024-11-21WarningsExact identifier
rxcui: 1010895
unii: V13007Z41A
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
unii: 6DC9Q167V3
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEClinic Pharma274611ea-7fc2-ba3f-e063-6294a90aa50f2024-11-19WarningsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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