FDA.reportPublic FDA data

NDC 76348-595-01 - Numb Gel Anesthetic

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
76348-595
Requested NDC
76348-595-01
Package NDCs from labels
76348-595-01, 76348-595-02
Manufacturer
RENU LABORATORIES, INC.
Effective date
2022-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NUMB Gel AnestheticRENU LABORATORIES, INC.2022-01-17HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-595-022024-01-30C16284748780-11030e365-4573-111a-e063-dadaa90a10e2NUMB Gel Anesthetic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-595-01Numb Gel Anesthetic28 g in 1 JARGEL283
76348-595-02Numb Gel Anesthetic1 in 1 BOXGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-595NUMB GEL ANESTHETIC (LIDOCAINE HCL) GEL [RENU LABORATORIES, INC.]3Legacy NDC, 2 package rows20220118_b4901def-ccf5-db77-e053-2a95a90a1bed.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 192 of 194 · 3,877 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidotholLIDOCAINE HCL, MENTHOLAsclemed USA, Inc.6d7adaca-67dd-4a4b-a85c-d1c2a568dee22022-09-09Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ethylicum (ETOH, aka Alcoholus)ETHYLICUM (ETOH, AKA ALCOHOLUS)Hahnemann Laboratories, INC.e1fef03a-ed76-4294-e053-2995a90aee672022-06-21Exact identifier
unii: 3K9958V90M
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
unii: ZY81Z83H0X
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
unii: ZY81Z83H0X
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENovitium Pharma LLCffb2d794-2c88-48a2-beff-d01b6fcea51f2022-03-25Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lydexa 4.12%LIDOCAINE HYDROCHLORIDEPureTek Corporationaa1c9d39-1283-8c6b-e053-2a95a90af5b52022-03-02Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
d5c9eac5-69d2-62be-e053-2a95a90a26a7b4901def-ccf5-db77-e053-2a95a90a1bed2022-01-17WarningsExact identifier
spl id: d5c9eac5-69d2-62be-e053-2a95a90a26a7
spl set id: b4901def-ccf5-db77-e053-2a95a90a1bed
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEInternational Medication Systems, Limited2c48cfac-81eb-4a81-8590-bc94574dd4c32021-12-14Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
unii: V13007Z41A
Flora PlusALOE, ALUMINA, ANTIMON CRUD, ARG NIT, CHELIDONIUM MAJ, GAMBOGIA, GRAPHITES, HYDRASTIS, LYCOPODIUM, SILICEANET Remediesfc1ced48-bd9f-4b3f-b786-573fba0729752021-01-21WarningsExact identifier
unii: ZY81Z83H0X

Reported adverse events (FAERS/openFDA)#

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