FDA.reportPublic FDA data

Leader Maximum Strength Hemorrhoidal Relief

Product NDC
70000-0650
11-digit product format
700000650
Labeler code
70000
Product ID
70000-0650_30dcc962-8024-3383-e063-6294a90afac6
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
CREAM
Route
TOPICAL
Labeler
Cardinal Health,Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
LIDOCAINE
Active strength
50 mg/g
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

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Maximum Strength Hemorrhoidal Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1366789

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0650-1Leader Maximum Strength Hemorrhoidal Relief1 in 1 CARTONCREAM12
70000-0650-1Leader Maximum Strength Hemorrhoidal Relief30 g in 1 TUBECREAM302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0650-1GM - Gram70000-0650a59de945-402d-4dfc-be6a-ab15affbbb5912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0650LEADER MAXIMUM STRENGTH HEMORRHOIDAL RELIEF (LIDOCAINE) CREAM [CARDINAL HEALTH,INC.]2Current NDC, 2 package rows20250323_65c780b0-7f47-4ae9-a847-c22deaaa2888.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366789lidocaine 5 % Rectal CreamPSN65c780b0-7f47-4ae9-a847-c22deaaa28882
1366789lidocaine 50 MG/ML Rectal CreamSCD65c780b0-7f47-4ae9-a847-c22deaaa28882
1366789lidocaine 5 % Rectal CreamSY65c780b0-7f47-4ae9-a847-c22deaaa28882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0650-1700000650011 TUBE in 1 CARTON (70000-0650-1) / 30 g in 1 TUBE1 tube2024-02-01NoNoHistorical