Home NDC 70000-0400 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 ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength 80; 10 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Calamine Plus
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 80 mg/mL PRAMOXINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234532 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0400-1 Leader Calamine Plus 177 mL in 1 CONTAINER LOTION 177 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0400 LEADER CALAMINE PLUS (ZINC OXIDE LOTION) LOTION [CARDINAL HEALTH, 110 DBA LEADER] 5 Current NDC, Legacy NDC, 1 package rows 20231223_81f29789-f794-1e64-e053-2a91aa0ac85e.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 39 of 68 · 1,350 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0400-1 70000040001 177 mL in 1 CONTAINER (70000-0400-1) 177 ml 2019-02-15 0000-00-00 No No Current