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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
88AYB867L5PRAMOXINE HYDROCHLORIDE637-58-1PRAMOXINE HYDROCHLORIDE
SOI2LOH54ZZINC OXIDE1314-13-2ZINC OXIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0400-170000040001177 mL in 1 CONTAINER (70000-0400-1) 177 ml2019-02-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LEADER Calamine PlusCardinal Health, 110 dba Leader2023-12-22HUMAN OTC DRUG LABEL5