Concept II

Product NDC
58443-0214
11-digit product format
584430214
Labeler code
58443
Product ID
58443-0214_9c5944f3-9387-b174-e053-2995a90ac030
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, octisalate, and octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-05-20
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
20 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
58443-0214-42024-01-30C16284748780-11030e365-3d0f-111a-e063-dadaa90a10e2Concept II SolScents Broad Spectrum SPF 15 Vanilla Silk

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0214-4Concept IISolScents Broad Spectrum SPF 15 Vanilla Silk236 mL in 1 BOTTLELOTION2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0214CONCEPT II SOLSCENTS BROAD SPECTRUM SPF 15 VANILLA SILK (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200121_280ad32b-75b7-286e-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0214-458443021404236 mL in 1 BOTTLE (58443-0214-4) 236 ml2013-05-200000-00-00NoNoCurrent