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 37 of 231 · 4,604 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunburn Relief GelLIDOCAINE HCLCVS Pharmacy, Inc.d7f52394-5cc1-48a6-ae89-9fc63b5157582026-04-06Warnings, Adverse reactionsExact identifier
application number: M017
unii: V13007Z41A
Pain-Relieving PatchCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4ecf4a6e-5c0f-7943-e063-6394a90a81cc2026-04-06WarningsExact identifier
application number: M017
unii: L7T10EIP3A
RAPID RELIEF0.025% CAPSAICIN PAIN PATCHRAPID AID VIET NAM COMPANY LIMITED4edbaa1a-6e44-4865-e063-6394a90a8cc32026-04-06WarningsExact identifier
application number: M017
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)269b9e7f-c5c8-4023-a3ea-e39040ade2712026-04-06WarningsExact identifier
unii: L7T10EIP3A
Capsaicin 0.1% CreamCAPSAICIN 0.1%Puretek Corporation4e83441b-cb6a-beb0-e063-6394a90a1b542026-04-03WarningsExact identifier
application number: M017
NeroCare Capsaicin Neuropathy Relief CreamCAPSAICINGuangzhou Tata Biotechnology Co., Ltd.4e89b7eb-0d84-dc57-e063-6394a90a7dd92026-04-03WarningsExact identifier
application number: M017
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
TheraCare Pain Relief PatchLIDOCAINE 4%Veridian Healthcare4e91da65-8191-6261-e063-6394a90a6bd52026-04-03WarningsExact identifier
application number: M017
HealthWise Roll-OnLIDOCAINE, MENTHOLVeridian Healthcare4e9306b5-949e-f7a9-e063-6394a90ae13a2026-04-03WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Dr SabharwalsLIDOCAINE 4% GEL PATCHDr. Sabharwal's Wound Care102399b6-5be9-ee5e-e063-6394a90a31982026-04-02WarningsExact identifier
application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVINGLIDOCAINE HYDROCHLORIDEScyberco Ltdac8eac04-ed5b-4c8e-9f9b-54d160b746062026-04-02WarningsExact identifier
application number: M017
unii: V13007Z41A
FifthPulse HydrocortisoneHYDROCORTISONEWeCare Products LLCf1fcb045-4a15-431b-9617-67eae9f87fbd2026-04-02WarningsExact identifier
application number: M017
ANIXIKE CreamMENTHOL 5% CREAMJiangxi Yudexi Pharmaceutical Co., LTD4e8510e6-c0c7-bf6b-e063-6294a90a3b002026-04-02WarningsExact identifier
application number: M017
unii: L7T10EIP3A
RAPID RELIEF0.025% CAPSAICIN PAIN PATCH835694ed549e8-0062-fb03-e063-6294a90aac652026-04-02WarningsExact identifier
application number: M017
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea2026-04-01WarningsExact identifier
unii: L7T10EIP3A
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEREMEDYREPACK INC.adc4dd69-45f3-48fe-bf85-f014b384c38e2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATECVS Pharmacy7e921988-ec66-38dc-e053-2a91aa0a73462026-04-01WarningsExact identifier
application number: M017
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINPreferred Pharmaceuticals, Inc.43a8f9c1-6cf1-4f27-9995-4f0ce08971da2026-04-01WarningsExact identifier
unii: L7T10EIP3A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e12026-04-01Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
The Best Numbing CreamTBNCThe Best Numbing Cream LLC4ca3923b-f586-0aaf-e063-6294a90a16c12026-03-31WarningsExact identifier
application number: M017

Reported adverse events (FAERS/openFDA)#

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