FDA.reportPublic FDA data

NDC 61010-5000-06 - 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
61010-5000-06
Package NDCs from labels
61010-5000-0, 61010-5000-1, 61010-5000-3, 61010-5000-4, 61010-5000-5, 61010-5000-6, 61010-5000-06
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 48 of 228 · 4,549 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic Mouth RinseEUCALYPTOLPerrigo Direct, Inc790843ce-88e2-4060-b61f-925fb30272da2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCAYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPerrigo Direct, Inc50776776-80aa-4098-8cf3-6daa0b305b152026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPerrigo Direct, Inccb4cf304-4f19-40cd-b480-9d89d19096842026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.bbf967e1-3a10-4e04-b7c5-2fcd80cc51742026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
unii: L7T10EIP3A
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEMeijer, Inc.e11390ec-99a3-4ff1-a3c8-ca909f4f67b52026-02-19Warnings, Adverse reactionsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.41b8d113-59e0-41e3-b852-0ec7541cad802026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.ec4907e1-d31c-4360-97d9-dc094a5a08ac2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.2aacfe5c-36c8-4890-b6c0-a9511346761e2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Aloe Vera GelLIDOCAINE HCL, MENTHOLMeijer, Inc.d0cc06c1-c0d5-42f0-82cd-8b704cbe1f462026-02-19Warnings, Adverse reactionsExact identifier
application number: M017
unii: L7T10EIP3A
unii: V13007Z41A
Tartar controlEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.191f01bb-d580-4e96-89d4-ab736b75c51c2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4b1a0e6f-aa68-421c-e063-6294a90a426e2026-02-18WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Veiurkiu External Analgesic CreamLIDOCAINEBLOOMWELL GARDENS LLC40ec5e6f-13dc-de04-e063-6294a90af5d52026-02-18WarningsExact identifier
application number: M017
External Analgesic Cream with Menthol 5%MENTHOL 5%BLOOMWELL GARDENS LLC402faa27-5305-c73d-e063-6394a90a36f22026-02-18WarningsExact identifier
application number: M017
unii: L7T10EIP3A
PAINGELMENTHOL, METHYL SALICYLATENACOR BUSINESS GROUP LLC4b1d55e2-cf83-ffbd-e063-6294a90ad52f2026-02-18WarningsExact identifier
application number: M017
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTarget Corporation563bdc23-7820-411a-b3c5-16514afc83d22026-02-18Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
cough suppressant and topical analgesicCAMPHOR, EUCALYPTUS OIL, MENTHOLTarget Corporationdf21d9d6-36a9-49cf-a29c-c4a573899bd52026-02-18Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEAdvagen Pharma Ltdae40021b-8df8-4b16-aac0-dcec88f76c7d2026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTarget Corporation55e29b2f-a51f-4473-a022-aa9b921beb872026-02-18Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Alocane Anti-ItchHYDROCORTISONE 1%Quest Products, LLC45252043-d41a-3cdd-e063-6394a90aa9e52026-02-18WarningsExact identifier
application number: M017

Reported adverse events (FAERS/openFDA)#

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