FDA.reportPublic FDA data

Leader Burn Relief

Product NDC
70000-0624
11-digit product format
700000624
Labeler code
70000
Product ID
70000-0624_10ba9afc-73fc-c8a3-e063-6294a90a8adc
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
SPRAY
Route
TOPICAL
Labeler
Cardinal Health
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-17
Substance
LIDOCAINE
Active strength
.5 g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Burn Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1442274Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0624-1Leader Burn Relief128 g in 1 BOTTLE, PLASTICSPRAY1282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0624-1GM - Gram70000-06241b680e2c-b72b-44e1-95c5-64a7b3bda22012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0624LEADER BURN RELIEF (LIDOCAINE) SPRAY [CARDINAL HEALTH]2Current NDC, 1 package rows20240207_f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2.zip

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 46 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Lidocaine Pain ReliefLIDOCAINEVeridian Healthcareee8cd550-64ee-432e-98e5-b68083179a3c2026-01-05WarningsExact identifier
application number: M017
REGENECARE HALIDOCAINE HCLMPM Medical LLC0eee554f-dfe0-433a-9665-8bdb952298882026-01-05WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLPAIN WIZARD LIMITED LIABILITY COMPANY2647bba1-87f4-3c16-e063-6394a90ae0c92026-01-05WarningsExact identifier
application number: M017
TheraCare Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcareefddd116-d753-425a-9ded-09b8045024e42026-01-05WarningsExact identifier
application number: M017
TheraCare Original MentholMENTHOLVeridian Healthcareea56e4e1-a758-428b-8758-ee31bb00ca822026-01-05WarningsExact identifier
application number: M017
Mugwort Patch (Cervical spine use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e220c-0d35-9ee0-e063-6294a90ab6892026-01-04WarningsExact identifier
application number: M017
Mugwort Patch (Lumbar spine use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e4b21-6d81-4cd3-e063-6394a90a18fe2026-01-04WarningsExact identifier
application number: M017
Mugwort Patch (Knee use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e86d2-3030-91eb-e063-6394a90a4db02026-01-04WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inc4a543f90-d43c-4487-b27e-f43394c6320d2026-01-04WarningsExact identifier
application number: M017
Doctor Hoys Pain Relief GelMENTHOL, CAMPHOR (SYNTHETIC)Dynamic Blending Specialists, Inc.50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a82026-01-02WarningsExact identifier
application number: M017
Doctor Hoys Pain Relief Gel Roll-OnMENTHOL, CAMPHOR (SYNTHETIC)Dynamic Blending Specialists, Inc.bf47acb2-6c90-4d5c-820b-447cac9305a42026-01-02WarningsExact identifier
application number: M017
Amino Rip Muscle Pain ReliefLIDOCAINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2bed5764-4217-4aa3-9d90-3b5460dcffa32026-01-02WarningsExact identifier
application number: M017
Menthozen CreamMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC63bb0283-cfbe-4e9c-8772-73062c0c8d052026-01-01WarningsExact identifier
application number: M017
Menthozen HydrogelMENTHOL, CAPSAICINVillage Pharma LLC4c979a71-7c8f-4dff-abae-bf4cdf8f67b42026-01-01WarningsExact identifier
application number: M017
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma LLCffb7831f-4ca9-4d73-8303-e9cd900789822026-01-01WarningsExact identifier
application number: M017
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.116ee6dc-9c49-2e11-e063-6394a90a44ed2026-01-01WarningsExact identifier
application number: M017
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb132026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES5adf457e-b4d0-30c8-e063-6294a90a64b92026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES490bc3b1-48bf-5437-e063-6394a90a90182026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5ae00308-0a8c-065c-e063-6394a90aff6b2026-01-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442274lidocaine 0.5 % Topical SprayPSNf4e8e3b7-fd84-bdbc-e053-2a95a90aeab22
1442274lidocaine 5 MG/ML Topical SpraySCDf4e8e3b7-fd84-bdbc-e053-2a95a90aeab22
1442274lidocaine 0.5 % Topical SpraySYf4e8e3b7-fd84-bdbc-e053-2a95a90aeab22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0624-170000062401128 g in 1 BOTTLE, PLASTIC (70000-0624-1) 128 g2023-02-17NoNoCurrent