Cream

Product NDC
61354-064
11-digit product format
613540064
Labeler code
61354
Product ID
61354-064_de5a11ba-8483-dabc-e053-2a95a90ac0c1
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide, Titanium dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Oxygen Development LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-05-06
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
5 mg/100mg; mg/100mg
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-064-012025-01-30C16284748780-12cef2736-9eac-d83d-e063-dadaa90ab31fTarte high - performance naturals BB tinted tratment primer Broad Spectrum SPF 30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-064-01Cream100 mg in 1 TUBELOTION1001
61354-064-01Cream1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-064CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC]1Legacy NDC, 2 package rows20220507_de5a11ba-8482-dabc-e053-2a95a90ac0c1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61354-064-01613540064011 TUBE in 1 CARTON (61354-064-01) > 100 mg in 1 TUBE1 tube2022-05-060000-00-00NoNoCurrent