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 58 of 62 · 1,229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
unii: HIE492ZZ3T
Family Wellness Pain Relief with LidocainePAIN RELIEF WITH LIDOCAINEFAMILY DOLLAR (Family Wellness)3a18119f-6c75-4cea-a990-97cb8a9589d42023-08-29WarningsExact identifier
unii: V13007Z41A
AccucaineLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.584642a8-9bed-4d86-bfaf-99018c180e342023-08-09Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 6DC9Q167V3
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 6DC9Q167V3
Bactine Max Antibiotic and Lidocaine Max Pain ReliefLIDOCAINEWellSpring Pharmaceutical Corporation71300df9-6113-4f25-93ca-28ad7e7f79de2023-06-08WarningsExact identifier
unii: V13007Z41A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6bcdbee5-014e-6b4c-e053-2a91aa0aecd22023-05-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC8968c61e-2686-0fe6-e053-2a95a90a15fa2023-05-23Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC858f3faa-e56e-51f9-e053-2a91aa0aa7212023-05-23Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6bdd64a8-b90e-57d4-e053-2a91aa0a39112023-05-22Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6947af02-f4e0-7f9c-e053-2a91aa0a45cd2023-05-22Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC86083fea-c064-4ef7-e053-2a91aa0ac17c2023-05-16Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC86093c75-6dde-bb16-e053-2991aa0ab6ef2023-05-16Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC79798b21-026d-1b4c-e053-2a91aa0a01292023-05-16Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC89691444-7bfb-3314-e053-2a95a90a268e2023-05-15Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC9c9655fd-89a9-77c8-e053-2a95a90a0c992023-05-15Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC9e412b4c-e24f-69ea-e053-2995a90ac6002023-05-10Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC9e049bbe-0f4d-988e-e053-2a95a90a36912023-05-10Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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