FDA.reportPublic FDA data

NDC 35781-0301-0 - Lidodose

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
35781-0301
Requested NDC
35781-0301-0
Package NDCs from labels
35781-0301-0, 35781-0301-5, 35781-0301-1
Manufacturer
Gensco Laboratories, LLC
Effective date
2022-10-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lidodose - Gensco Laboratories, LLCGensco Laboratories, LLC2022-10-04HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
35781-0301-12023-07-28LidoDose Topical Anesthetic
35781-0301-52023-07-28LidoDose Topical Anesthetic
35781-0301-12022-10-05LidoDose Topical Anesthetic
35781-0301-52022-10-05LidoDose Topical Anesthetic
35781-0301-12022-07-29LidoDose Topical Anesthetic
35781-0301-52022-07-29LidoDose Topical Anesthetic
35781-0301-12020-09-14LidoDose Topical Anesthetic
35781-0301-52020-09-14LidoDose Topical Anesthetic
35781-0301-12020-07-22LidoDose Topical Anesthetic
35781-0301-52020-07-22LidoDose Topical Anesthetic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35781-0301-0Lidodose1 mL in 1 POUCHGEL17
35781-0301-1Lidodose100 in 1 BOXGEL1007
35781-0301-5Lidodose25 in 1 BOXGEL257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35781-0301LIDODOSE (LIDOCAINE HYDROCHLORIDE) GEL [GENSCO LABORATORIES, LLC]7Legacy NDC, 3 package rows20221006_0b3e8433-4f93-4f01-9df0-020fb6922bce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35781-0301-0ML - Milliliter35781-0301ffc9fee0-57af-4fd1-bdfe-2944d888a28312018-08-13
35781-0301-1ML - Milliliter35781-0301ee48ab42-3c99-400e-ad2a-4cf6a13cb5f812019-04-11
35781-0301-5ML - Milliliter35781-0301cf10e88e-9a11-4224-9050-ee0310a8b30912018-08-13

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 56 of 97 · 1,928 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst952ffcce-0ec4-61c9-e053-2995a90a84af2025-06-16Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
unii: 4T6H12BN9U
HAND-I-SAN75% ISOPROPYL ALCOHOL HAND SANITIZERZECO, LLC37627a51-cf31-013c-e063-6294a90ae13a2025-06-13WarningsExact identifier
unii: ND2M416302
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
unii: 4T6H12BN9U
Diabecin HRLIDOCAINE HCL, BENZALKONIUM CHLORIDEPureTek Corporation36c60fe2-5b7b-83dd-e063-6294a90ad4672025-06-10Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
unii: 4T6H12BN9U
Singular Wipes fragrance freeISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC6026cb8b-4556-41bd-a7b9-d9bb309005c72025-06-06WarningsExact identifier
unii: ND2M416302
Travel WipesISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC818b4280-a1cb-4c69-908f-f687f7c84ad92025-06-06WarningsExact identifier
unii: ND2M416302
RECOVERY NumbingLIDOCAINE HCLRenu Laboratories, LLCe4e05cae-56a6-b2b3-e053-2a95a90a104b2025-06-06WarningsExact identifier
unii: V13007Z41A
The Pharma-C Company 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLKleen Test Products Corporationa0f93dac-7baa-4f79-b6a0-3cabe52806bb2025-06-04WarningsExact identifier
unii: ND2M416302
LidoGuardLIDOCAINE HCLViolaCare, Inc.531383aa-4f0f-4fe0-91f4-d809b39f160f2025-06-04WarningsExact identifier
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
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHHUZHOU JUNDA INDUSTRY CO., LTD.361dcd60-c194-4c8b-e063-6294a90a425b2025-05-27WarningsExact identifier
unii: ND2M416302
HCS Alcohol Prep Pad LargeISOPROPYL ALCOHOLConcordance Healthcare Solutions, LLC.2cbe0c4c-440d-4f6c-88e8-363d3c798fba2025-05-27WarningsExact identifier
unii: ND2M416302
VLITEPRO First Aid WipesISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co., Ltd.35a7873a-e340-aae3-e063-6294a90a767f2025-05-26WarningsExact identifier
unii: ND2M416302
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
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.29e5c152-15d7-4080-abf0-f76f8e9cbf5a2025-05-16WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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