Barrier Cream

Product NDC
58518-040
11-digit product format
585180040
Labeler code
58518
Product ID
58518-040_fbc1e407-09f5-1d83-e053-6294a90aef0f
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Avasol LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-01
Substance
ZINC OXIDE
Active strength
100 mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Barrier Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE100 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58518-040-02Barrier Cream59 mL in 1 POUCHCREAM593
58518-040-03Barrier Cream28 mL in 1 TUBECREAM283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58518-040BARRIER CREAM (ZINC OXIDE) CREAM [AVASOL LLC]2Current NDC, Legacy NDC, 2 package rows20230425_bc6a2736-faa6-46d3-af9b-a70f0762e9ce.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58518-040-025851800400259 mL in 1 POUCH (58518-040-02) 59 ml2022-01-010000-00-00NoNoCurrent
58518-040-035851800400328 mL in 1 TUBE (58518-040-03) 28 ml2022-01-010000-00-00NoNoCurrent