Powder

Product NDC
61354-188
11-digit product format
613540188
Labeler code
61354
Product ID
61354-188_41c09cb9-0e08-3abc-e063-6294a90a7883
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Oxygen Development LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-27
Substance
TITANIUM DIOXIDE
Active strength
10 mg/100mg
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE10 mg/100mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-188-01Powder1 in 1 CARTONPOWDER14
61354-188-01Powder100 mg in 1 CUPPOWDER1004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61354-188-01613540188011 CUP in 1 CARTON (61354-188-01) / 100 mg in 1 CUP1 cup2023-10-27NoNoHistorical