Cream

Product NDC
78518-006
11-digit product format
785180006
Labeler code
78518
Product ID
78518-006_46e05579-7673-e42b-e063-6294a90acd3c
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
MONAT GLOBAL CORP
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-12
Substance
ZINC OXIDE
Active strength
18.8 mg/100mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE18.8 mg/100mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78518-006-01Cream35 mg in 1 TUBECREAM353
78518-006-01Cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78518-006CREAM (ZINC OXIDE) CREAM [MONAT GLOBAL CORP]2Current NDC, Legacy NDC, 2 package rows20230812_e922d89c-4232-77d8-e053-2995a90a85e5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78518-006-01785180006011 TUBE in 1 CARTON (78518-006-01) / 35 mg in 1 TUBE1 tube2022-09-120000-00-00NoNoCurrent