FDA.reportPublic FDA data

Leader Calamine Plus

Product NDC
70000-0400
11-digit product format
700000400
Labeler code
70000
Product ID
70000-0400_0d1994b2-3c1b-6322-e063-6394a90a1b6c
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide lotion
Dosage form
LOTION
Route
TOPICAL
Labeler
Cardinal Health, 110 dba Leader
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-15
Substance
PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
10; 80 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [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 Calamine Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC OXIDE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, SOI2LOH54Z
Rxcui1234532

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0400-1Leader Calamine Plus177 mL in 1 CONTAINERLOTION1775

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0400-1ML - Milliliter70000-040002eb5c5d-1078-4172-acc3-41965dc92c4e12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0400LEADER CALAMINE PLUS (ZINC OXIDE LOTION) LOTION [CARDINAL HEALTH, 110 DBA LEADER]5Current NDC, Legacy NDC, 1 package rows20231223_81f29789-f794-1e64-e053-2a91aa0ac85e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN81f29789-f794-1e64-e053-2a91aa0ac85e5
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD81f29789-f794-1e64-e053-2a91aa0ac85e5
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY81f29789-f794-1e64-e053-2a91aa0ac85e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0400-170000040001177 mL in 1 CONTAINER (70000-0400-1) 177 ml2019-02-150000-00-00NoNoCurrent