calamine

Product NDC
0363-9410
11-digit product format
003639410
Labeler code
0363
Product ID
0363-9410_29f99f0a-e520-6d9d-e063-6394a90afb57
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
WALGREEN COMPANY
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-16
Substance
ZINC OXIDE
Active strength
160 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
calamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui617954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9410-97calamine177 mL in 1 BOTTLELOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9410CALAMINE (CALAMINE AND ZINC OXIDE) LOTION [WALGREEN COMPANY]3Current NDC, 1 package rows20241225_fed3026b-3473-26fe-e053-6294a90a8aa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSNfed3026b-3473-26fe-e053-6294a90a8aa23
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCDfed3026b-3473-26fe-e053-6294a90a8aa23
617954calamine 8 % / zinc oxide 8 % Topical LotionSYfed3026b-3473-26fe-e053-6294a90a8aa23
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSYfed3026b-3473-26fe-e053-6294a90a8aa23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9410-9700363941097177 mL in 1 BOTTLE (0363-9410-97) 177 ml2023-10-16NoNoHistorical