FDA.reportPublic FDA data

Calamine

Product NDC
0904-2533
11-digit product format
009042533
Labeler code
0904
Product ID
0904-2533_4a057dbb-483c-a4b4-e063-6394a90aa36a
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
Major Pharmaceuticals
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-07
Substance
FERRIC OXIDE RED; ZINC OXIDE
Active strength
80; 80 mg/mL; mg/mL
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/mL
ZINC OXIDE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, SOI2LOH54Z
Rxcui617954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-2533-21Calamine177 mL in 1 BOTTLE, PLASTICLOTION17715

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-2533-21ML - Milliliter0904-2533918d193f-eb73-474a-b375-ecfe47fd756e12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G675CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G675CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VNCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-2533CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]13Current NDC, Legacy NDC, 1 package rows20250412_c25be68d-834a-4959-8d47-01ec789406ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSNc25be68d-834a-4959-8d47-01ec789406ba15
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCDc25be68d-834a-4959-8d47-01ec789406ba15
617954calamine 8 % / zinc oxide 8 % Topical LotionSYc25be68d-834a-4959-8d47-01ec789406ba15
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSYc25be68d-834a-4959-8d47-01ec789406ba15
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN326f3d80-c1bf-4cf0-a662-58e02ed7ee676
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD326f3d80-c1bf-4cf0-a662-58e02ed7ee676
617954calamine 8 % / zinc oxide 8 % Topical LotionSY326f3d80-c1bf-4cf0-a662-58e02ed7ee676
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY326f3d80-c1bf-4cf0-a662-58e02ed7ee676
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN66e98554-e158-a519-e053-2a91aa0a67835
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD66e98554-e158-a519-e053-2a91aa0a67835
617954calamine 8 % / zinc oxide 8 % Topical LotionSY66e98554-e158-a519-e053-2a91aa0a67835
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY66e98554-e158-a519-e053-2a91aa0a67835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-2533-2100904253321177 mL in 1 BOTTLE, PLASTIC (0904-2533-21) 177 ml2013-01-070000-00-00NoNoCurrent