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 8 of 99 · 1,967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst2177b6fe-aa37-6f6b-e063-6294a90af09a2026-07-10Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Tina Davies IceCreamLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC6a2b3199-f405-4455-9a02-8885d24eef9c2026-07-09WarningsExact identifier
unii: V13007Z41A
HOMWIS CreamHOMWIS CREAMShenzhen Ishan Technology Co., Ltd51aeec61-bddd-fea1-e063-6394a90a2e0b2026-07-09WarningsExact identifier
unii: 4T6H12BN9U
Nervionix Pro Magnesium IceLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporatedc11e0963-90fb-48c6-938a-3dcbbad17aca2026-07-09WarningsExact identifier
unii: V13007Z41A
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
unii: 4T6H12BN9U
LidexaGel 5%LIDOCAINE HCLOncora Pharma, LLCb45a7d2f-111f-4390-9b90-570b1c9f5ffc2026-07-08Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: ND2M416302
Walgreens Baby Healing BalmPETROLATUMWalgreens561c1e1e-e896-d6e9-e063-6394a90ac0e72026-07-08WarningsExact identifier
unii: 4T6H12BN9U
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc561c601f-c2cd-f09c-e063-6294a90adb452026-07-08WarningsExact identifier
unii: 4T6H12BN9U
AD Overnight HealingAD OVERNIGHT HEALINGWellSpring Pharmaceutical Corporation57c29db6-da0c-4b28-86c0-6ac1b71224282026-07-07WarningsExact identifier
unii: 4T6H12BN9U
70%ISOPROPYL ALCOHOLSave-A-Lot Food Stores Ltda592326c-c062-4ebf-b8dd-83f7e6f2f22b2026-07-07Warnings, Adverse reactionsExact identifier
unii: ND2M416302
FDS intimate Whole Body Medicated ChafingFDS INTIMATE WHOLE BODY MEDICATED CHAFINGWellSpring Pharmaceutical Corporationef01fcd8-2fe4-4076-a4d4-e730a5c2b31c2026-07-07WarningsExact identifier
unii: 4T6H12BN9U
AD First Aid MultipurposeAD FIRST AID MULTIPURPOSEWellSpring Pharmaceutical Corporation999989d8-21c2-4380-b4c1-e5421189f6ed2026-07-07WarningsExact identifier
unii: 4T6H12BN9U
AD Anti-ChafingAD ANTI-CHAFINGWellSpring Pharmaceutical Corporationd272ab4a-eb18-4f64-b925-fccf637dbb022026-07-06WarningsExact identifier
unii: 4T6H12BN9U
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
JJ Care BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.d69ebc53-8552-449a-a973-f211328a3d3e2026-07-03WarningsExact identifier
unii: V13007Z41A
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Petroleum Skin ProtectantWHITE PETROLATUMPublix Super Markets, Inc.c94b5574-3fd7-48a8-94ef-db5d7184fa102026-07-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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