Australian Gold

Product NDC
58443-0508
11-digit product format
584430508
Labeler code
58443
Product ID
58443-0508_d58df976-b79b-cd8a-e053-2a95a90a8cf6
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
2020-03-24
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
44 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0508-42024-01-30C16284748780-11030e365-03b1-111a-e063-dadaa90a10e2Australian Gold Botanical Sunscreen 70 Mineral Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0508-4Australian GoldBotanicals Sunscreen 70 Minerals147 mL in 1 TUBELOTION1471

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0508AUSTRALIAN GOLD BOTANICALS SUNSCREEN 70 MINERALS (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.]1Legacy NDC, 1 package rows20220115_d58df976-b79a-cd8a-e053-2a95a90a8cf6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0508-458443050804147 mL in 1 TUBE (58443-0508-4) 147 ml2020-03-240000-00-00NoNoCurrent