FDA.reportPublic FDA data

NDC 61010-5000-01 - Lidocaine Hydrochloride

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
61010-5000
Requested NDC
61010-5000-01
Package NDCs from labels
61010-5000-0, 61010-5000-1, 61010-5000-3, 61010-5000-4, 61010-5000-5, 61010-5000-6, 61010-5000-01
Manufacturer
Safetec of America, Inc.
Effective date
2024-02-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
61010-5000, Burn GelSafetec of America, Inc.2024-02-07HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61010-5000-02024-02-0761010-5000, Burn Gel
61010-5000-12024-02-0761010-5000, Burn Gel
61010-5000-32024-02-0761010-5000, Burn Gel
61010-5000-42024-02-0761010-5000, Burn Gel
61010-5000-52024-02-0761010-5000, Burn Gel
61010-5000-62024-02-0761010-5000, Burn Gel
61010-5000-02024-01-3061010-5000, Burn Gel
61010-5000-12024-01-3061010-5000, Burn Gel
61010-5000-32024-01-3061010-5000, Burn Gel
61010-5000-42024-01-3061010-5000, Burn Gel
61010-5000-52024-01-3061010-5000, Burn Gel
61010-5000-62024-01-3061010-5000, Burn Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5000-0Lidocaine Hydrochloride3.3 g in 1 PACKETGEL3.35
61010-5000-1Lidocaine Hydrochloride121.2 g in 1 BOTTLEGEL121.25
61010-5000-3Lidocaine Hydrochloride0.9 g in 1 POUCHGEL0.95
61010-5000-4Lidocaine Hydrochloride144 in 1 CARTONGEL1445
61010-5000-4Lidocaine Hydrochloride0.9 g in 1 POUCHGEL0.95
61010-5000-5Lidocaine Hydrochloride0.9 g in 1 POUCHGEL0.95
61010-5000-5Lidocaine Hydrochloride25 in 1 CARTONGEL255
61010-5000-6Lidocaine Hydrochloride0.9 g in 1 PACKETGEL0.95
61010-5000-6Lidocaine Hydrochloride10 in 1 BOXGEL105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5000LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]5Current NDC, Legacy NDC, 9 package rows20240208_1c5eb3b3-79b3-472a-ae36-ec6a7dc72925.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
LidocaineACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XLIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
mentholINACTIVE INGREDIENTL7T10EIP3ALIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
trolamineINACTIVE INGREDIENT9O3K93S3TKLIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2

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 51 of 231 · 4,604 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLC2022986a-2a93-4291-887c-c23f2b2c83a72026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLC4ad7818e-caee-49f0-81e8-bda6fbd64ea52026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLCef20af6a-4547-4b63-8ffe-989112e3030f2026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLYour Military Exchanges9073bc29-434e-4d41-9f22-cf9e57c2f9ad2026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLYour Military Exchangesc7350c31-02e4-4fe8-b334-c24a8eb724952026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMPMENTHOL, CAMPHORWorldwide Cosmetics, Inc459d64a9-0538-57c8-e063-6394a90a61552026-02-12WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOLWalgreen Co.cba60e9d-5f12-4c56-9fa5-6ce1514fc2b02026-02-12Warnings, Adverse reactionsExact identifier
application number: M017
unii: L7T10EIP3A
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLWalgreen Co.55807b18-42ed-45a7-845e-fcf7f5d70d042026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreen Co.5cb2eabe-46f2-48c0-9a4c-6518513ed34f2026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Medicated Body PowderMENTHOLWalmart Stores Incafd337b7-d76e-f17a-e053-2a95a90abac72026-02-12WarningsExact identifier
application number: M017
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreen Co.be116a1c-697a-451b-aa2e-d39bdc2f6ff82026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreen Co.0780b123-a401-405b-9e50-6be818d71d392026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: L7T10EIP3A
Lidocaine Hydrochloride 2%LIDOCAINE HYDROCHLORIDEAldermed Inc.4977b722-d08d-3d9e-e063-6294a90a90352026-02-12WarningsExact identifier
application number: M017
rxcui: 1011852
unii: V13007Z41A
LMNOOPMENTHOLShenzhen iShan Technology Co., Ltdd0f718e4-91dd-51d2-e053-2a95a90ae44f2026-02-12WarningsExact identifier
unii: L7T10EIP3A
PETROLATUMISHANCARE HEMORRHOID CREAMShenzhen Ishan Technology Co., Ltdd22536d0-b935-6a20-e053-2a95a90af3ed2026-02-12WarningsExact identifier
unii: L7T10EIP3A
iShanCare PAIN RELIEF Gel-PatchMENTHOLShenzhen Ishan Technology Co., Ltd29b5c3c2-b9d5-5198-e063-6294a90ab7a42026-02-12WarningsExact identifier
unii: L7T10EIP3A
iShanCare PAIN RELIEF Gel-PatchLIDOCARINE AND MENTHOLShenzhen Ishan Technology Co., Ltd29b36a93-438e-efd9-e063-6394a90a037a2026-02-12WarningsExact identifier
unii: L7T10EIP3A
iShanCare PAIN RELIEF Gel-PatchLIDOCARINEShenzhen Ishan Technology Co., Ltd29739289-42b6-0047-e063-6394a90ad9312026-02-12WarningsExact identifier
unii: L7T10EIP3A
Yimimde PAIN RELIEF Gel-PatchLIDOCARINE AND MENTHOLShenzhen Ishan Technology Co., Ltd29b4fc6d-a588-c1a4-e063-6394a90ae9dd2026-02-12WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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