Calamine

Product NDC
46122-809
11-digit product format
461220809
Labeler code
46122
Product ID
46122-809_498db13a-f81f-8a0a-e063-6294a90a814c
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine
Dosage form
LOTION
Route
TOPICAL
Labeler
AMERISOURCE BERGEN
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-23
Substance
FERRIC OXIDE RED; ZINC OXIDE
Active strength
80; 80 mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED80 mg/100mL
ZINC OXIDE80 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, SOI2LOH54Z
Rxcui617954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-809-29Calamine177 mL in 1 BOTTLE, PLASTICLOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-809CALAMINE LOTION [AMERISOURCE BERGEN]2Current NDC, 1 package rows20250426_90d9d908-57ea-4062-ade0-8a4888939c91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN90d9d908-57ea-4062-ade0-8a4888939c913
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD90d9d908-57ea-4062-ade0-8a4888939c913
617954calamine 8 % / zinc oxide 8 % Topical LotionSY90d9d908-57ea-4062-ade0-8a4888939c913
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY90d9d908-57ea-4062-ade0-8a4888939c913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-809-2946122080929177 mL in 1 BOTTLE, PLASTIC (46122-809-29) 177 ml2025-04-23NoNoCurrent