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 10 of 99 · 1,967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Swab Applicator Brushes Iodine (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD54e83df5-bbeb-d068-e063-6394a90ad5132026-06-23WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLADUSA Distribution, LLCf340dd7e-6412-4621-a818-2592ca78d0f22026-06-23Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLCd95a9736-345b-4b7e-9b24-23edb3cbf7e82026-06-23Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLC7e066163-6629-43ad-b0b8-09c16fe94a0d2026-06-23Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Isopropyl Rubbing Alcohol 70ISOPROPYL ALCOHOLDelon Laboratories (1990) Ltd.fb481568-0c51-421f-9b73-adb4c84645aa2026-06-22WarningsExact identifier
unii: ND2M416302
MedlineISOPROPYL ALCOHOLMedline Industries, LP495076e9-3187-6bfa-e063-6394a90a01f52026-06-22WarningsExact identifier
unii: ND2M416302
LIDOCAINE HCl AND EPINEPHRINELIDOCAINE HCL AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta09613b2-4337-5b52-e053-2995a90ab74b2026-06-19Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Petroleum Skin ProtectantWHITE PETROLATUMWalmart Inc.e294a871-ae73-4a4f-89a3-9ebf0b4fd03a2026-06-19Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
unii: V13007Z41A
Baby HealingOintmentPETROLATUMFoshan Desha Biotechnology Co., Ltd.5488b81a-e5fe-1452-e063-6394a90a2ae42026-06-18WarningsExact identifier
unii: 4T6H12BN9U
Jell with Vitamin A DLANOLIN, PETROLATUMJell Pharmaceuticals Pvt Ltd.d976e5f0-1be5-d9c4-e053-2a95a90a44a42026-06-17WarningsExact identifier
unii: 4T6H12BN9U
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLP & L Development, LLCfcda76cb-63c4-4e81-9e0a-13be506a81502026-06-17WarningsExact identifier
unii: ND2M416302
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lidozall ProLIDOCAINE HYDROCHLORIDEV2 Pharma LLCecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff2026-06-16WarningsExact identifier
unii: V13007Z41A
70%ISOPROPYL ALCOHOLMeijer, Inc.7b1f93ff-5eeb-4da1-8f02-7c47d713689a2026-06-15Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMeijer, Inc.531cea18-9609-4d78-876d-3ba5d2d1e16f2026-06-15Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMeijer, Inc.b0d302c2-58a0-4c3e-9c4a-fd34de40c0342026-06-15Warnings, Adverse reactionsExact identifier
unii: ND2M416302
CVS Healing Balm Skin ProtectantPETROLATUMCVSdf711f93-71bd-4fbe-835c-50eaa9c15e072026-06-15WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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