Calamine

Product NDC
55319-063
11-digit product format
553190063
Labeler code
55319
Product ID
55319-063_4b931e99-fa6e-6400-e063-6394a90a9874
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
Family Dollar Stores, Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-07-15
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
55319-063-30Calamine177 mL in 1 BOTTLE, PLASTICLOTION17720

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-063CALAMINE (FERRIC OXIDE RED) LOTION [FAMILY DOLLAR SERVICES, INC.]18Current NDC, Legacy NDC, 1 package rows20240831_1a03331e-3676-451c-be22-9a547e8ae6e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN1a03331e-3676-451c-be22-9a547e8ae6e220
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD1a03331e-3676-451c-be22-9a547e8ae6e220
617954calamine 8 % / zinc oxide 8 % Topical LotionSY1a03331e-3676-451c-be22-9a547e8ae6e220
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY1a03331e-3676-451c-be22-9a547e8ae6e220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-063-3055319006330177 mL in 1 BOTTLE, PLASTIC (55319-063-30) 177 ml1989-07-150000-00-00NoNoCurrent