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 16 of 98 · 1,954 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70%ISOPROPYL ALCOHOLPerrigo Direct, Incf953a249-07ad-40a1-8aea-b2d419fd3d4d2026-04-07Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Dermatool Nerve CareLIDOCAINE HCL, MENTHOLPapalo Group, LLC4ee40c96-9350-4c68-e063-6294a90ac8122026-04-07WarningsExact identifier
unii: V13007Z41A
Sunburn Relief GelLIDOCAINE HCLCVS Pharmacy, Inc.d7f52394-5cc1-48a6-ae89-9fc63b5157582026-04-06Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
PetroleumWHITE PETROLATUMCVS Pharmacy, Inc.4dc08832-e610-4e62-a6af-cadaa339e39e2026-04-06Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMAmazon.com Services LLC616ef87d-1518-46aa-8e12-9a1b678d49802026-04-06Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Isopropyl AlcoholISOPROPYL ALCOHOLWinCo Foods, LLCc22a5fc3-78f5-4660-96a6-479ca6f776022026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLWinCo Foods, LLC2b48ee19-8f0c-4b36-855d-7909dde5c8712026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
50% RubbingISOPROPYL ALCOHOLPerrigo Direct, Inc698bede7-4fc1-4e85-8ac4-d735f409cfae2026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baade5c-e759-d98f-e063-6394a90aa0562026-04-03WarningsExact identifier
unii: 4T6H12BN9U
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
TATTOO NUMBX NUMBING PAIN RELIEVINGLIDOCAINE HYDROCHLORIDEScyberco Ltdac8eac04-ed5b-4c8e-9f9b-54d160b746062026-04-02WarningsExact identifier
unii: V13007Z41A
Medt PadISOPROPYL ALCOHOLCarelife (USA) Inc.74a05c37-becd-4c93-96cb-79f69add5e4d2026-04-02WarningsExact identifier
unii: ND2M416302
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEREMEDYREPACK INC.adc4dd69-45f3-48fe-bf85-f014b384c38e2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Walgreens Swimmers EarISOPROPYL ALCOHOLWalgreens Co3fb65a5c-c47f-ef2b-e063-6394a90af21a2026-04-01WarningsExact identifier
unii: ND2M416302
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e12026-04-01Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCIProstat First Aid4cd5d67d-43d8-f6d2-e063-6394a90a40702026-03-31WarningsExact identifier
unii: V13007Z41A
Burn MistLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesc53ab9dd-351a-400b-b873-4f396e0af54d2026-03-31WarningsExact identifier
unii: V13007Z41A
Isopro First AidISOPROPYL ALCOHOLWater-Jel Technologiesf38563f5-ee54-4979-9157-4bf8fd60daab2026-03-31WarningsExact identifier
unii: ND2M416302
Satohap Lidocaine Hydrochloride 4 Percent Pain RelievingLIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.f7faddb2-5153-4fdd-a5ef-778182cef4602026-03-31WarningsExact identifier
unii: V13007Z41A
FlavaltaLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.3f9f9b4f-bf6c-4b57-ac1a-98fd1a9a369d2026-03-31Warnings, Adverse reactionsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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