Austalian Gold

Product NDC
58443-0319
11-digit product format
584430319
Labeler code
58443
Product ID
58443-0319_a56133c5-fba7-0c1b-e053-2995a90afcf4
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-05-15
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
43 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0319-42023-01-30C16284748780-1f386c64a-11fa-0266-e053-dadaa90a7c1aAustralian Gold Botanical Sunscreen Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0319-4Austalian GoldBroad Spectrum SPF 50 Sunscreen147 mL in 1 BOTTLELOTION1471

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0319AUSTALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.]1Legacy NDC, 1 package rows20200512_a5612950-ae13-4cdc-e053-2a95a90abb78.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0319-458443031904147 mL in 1 BOTTLE (58443-0319-4) 147 ml2017-05-150000-00-00NoNoCurrent