FDA.reportPublic FDA data

NDC 61010-5100-05 - 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
61010-5100
Requested NDC
61010-5100-05
Package NDCs from labels
61010-5100-4, 61010-5100-5, 61010-5100-05
Manufacturer
Acme United Corporation
Effective date
2024-11-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lidocaine Hydrochloride - Acme United CorporationAcme United Corporation2024-11-12HUMAN OTC DRUG LABEL
61010-5100, Burn SpraySafetec of America, Inc.2024-02-07HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61010-5100-32024-02-1361010-5100, Burn Spray
61010-5100-42024-02-1361010-5100, Burn Spray
61010-5100-52024-02-1361010-5100, Burn Spray
61010-5100-32024-01-3061010-5100, Burn Spray
61010-5100-42024-01-3061010-5100, Burn Spray
61010-5100-52024-01-3061010-5100, Burn Spray
61010-5100-32020-03-1061010-5100, Burn Spray
61010-5100-32020-01-3161010-5100, Burn Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5100-4Lidocaine Hydrochloride59.1 mL in 1 BOTTLE, SPRAYLIQUID59.17
61010-5100-5Lidocaine Hydrochloride118 mL in 1 BOTTLE, SPRAYLIQUID1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5100LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]7Current NDC, Legacy NDC, 2 package rows20240214_8eb3e7e2-26e5-430e-89aa-40a0367c637e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4
LidocaineACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XLIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4
waterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4

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 1 of 185 · 3,700 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.23c8f711-e458-479a-9ab0-dcc851311e242026-09-10Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
unii: V13007Z41A
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
unii: V13007Z41A
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
rxcui: 1010769
unii: V13007Z41A
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
rxcui: 1010769
unii: V13007Z41A
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
unii: V13007Z41A
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
unii: V13007Z41A
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: V13007Z41A
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Lidocaine ViscousLIDOCAINE HYDROCHLORIDEREMEDYREPACK INC.6f8d20d2-6a91-4a5b-bfe8-f1baada384422026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017

Reported adverse events (FAERS/openFDA)#

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