Concept II

Product NDC
58443-0212
11-digit product format
584430212
Labeler code
58443
Product ID
58443-0212_9c5944f3-939c-b174-e053-2995a90ac030
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, octocrylene and oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-05-23
Marketing end
0000-00-00
Substance
OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0212-42024-01-30C16284748780-11030e365-4f1b-111a-e063-dadaa90a10e2Concept II SolScents Broad Spectrum SPF 30 Angelica

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0212-4Concept IISolScents Broad Spectrum SPF 30 Angelica236 mL in 1 BOTTLELOTION2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0212CONCEPT II SOLSCENTS BROAD SPECTRUM SPF 30 ANGELICA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200121_27fb491a-02d8-60df-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0212-458443021204236 mL in 1 BOTTLE (58443-0212-4) 236 ml2013-05-230000-00-00NoNoCurrent