Leader Anti-Itch

Product NDC
70000-0546
11-digit product format
700000546
Labeler code
70000
Product ID
70000-0546_43fa4c6d-3b73-48ab-e063-6394a90ae0f4
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
LOTION
Route
TOPICAL
Labeler
LEADER/Cardinal Helath 110, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-21
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
.5; .5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Anti-Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).5 g/100g
MENTHOL.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0546-12024-01-04C16284748780-1f386c64a-37ea-0266-e053-dadaa90a7c1aLeader Original Anti Itch Lotion
70000-0546-12023-01-30C16284748780-1f386c64a-37ea-0266-e053-dadaa90a7c1aLeader Original Anti Itch Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0546-1Leader Anti-Itch212 g in 1 BOTTLE, PUMPLOTION2127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0546-1ML - Milliliter70000-0546b2398c74-4403-44a7-90c3-99f5bae4f75a12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0546LEADER ANTI-ITCH (CAMPHOR, MENTHOL) LOTION [LEADER/CARDINAL HELATH 110, INC.]6Current NDC, Legacy NDC, 1 package rows20241208_9ca985c6-5017-0558-e053-2995a90a8202.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0546-170000054601212 g in 1 BOTTLE, PUMP (70000-0546-1) 212 g2020-01-210000-00-00NoNoCurrent