Calamine

Product NDC
68788-0292
11-digit product format
687880292
Labeler code
68788
Product ID
68788-0292_671e5bc7-7fa2-48d7-b251-9b1249d2dfa6
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
347
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-19
Substance
FERRIC OXIDE RED; ZINC OXIDE
Active strength
8; 8 g/mL; mg/mL
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
FERRIC OXIDE RED8 g/mL
ZINC OXIDE8 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, SOI2LOH54Z
Rxcui617954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-0292-1Calamine177 mL in 1 BOTTLE, PLASTICLOTION1776

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-0292-1ML - Milliliter68788-0292f4aef026-c890-422d-90f1-6ad4552ab24a12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-0292CALAMINE (FERRIC OXIDE RED) LOTION [PREFERRED PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 1 package rows20250215_326f3d80-c1bf-4cf0-a662-58e02ed7ee67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-0292-168788029201177 mL in 1 BOTTLE, PLASTIC (68788-0292-1) 177 ml2018-04-190000-00-00NoNoCurrent