Humco Calamine

Product NDC
0395-0413
11-digit product format
003950413
Labeler code
0395
Product ID
0395-0413_52b9f60d-7ae7-26c8-e063-6294a90acc20
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine 8% and Zinc Oxide 8%
Dosage form
LOTION
Route
TOPICAL
Labeler
Humco holding Group, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
0395-0413-96Humco Calamine177 mL in 1 BOTTLE, PLASTICLOTION1778

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0413-96ML - Milliliter0395-04137388d9e7-558f-47b8-9386-b0372be86ab312014-04-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0413HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]7Current NDC, Legacy NDC, 1 package rows20231216_f7dcd959-fb98-43bb-8dd3-a662bf8a053c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSNf7dcd959-fb98-43bb-8dd3-a662bf8a053c8
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCDf7dcd959-fb98-43bb-8dd3-a662bf8a053c8
617954calamine 8 % / zinc oxide 8 % Topical LotionSYf7dcd959-fb98-43bb-8dd3-a662bf8a053c8
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSYf7dcd959-fb98-43bb-8dd3-a662bf8a053c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-0413-9600395041396177 mL in 1 BOTTLE, PLASTIC (0395-0413-96) 177 ml2017-11-130000-00-00NoNoCurrent