FDA.reportPublic FDA data

Protective Day

Product NDC
51861-060
Requested package NDC
51861-060-00
11-digit product format
518610060
Labeler code
51861
Product ID
51861-060_c7166975-cb95-b055-e053-2a95a90a68e0
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
USANA Health Sciences, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-08-01
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE
Active strength
30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51861-06051861-060-00DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51861-060-002023-02-17C16284748780-1f386c649-e4af-0266-e053-dadaa90a7c1aProtective Day Lotion
51861-060-002023-01-30C16284748780-1f386c649-e4af-0266-e053-dadaa90a7c1aProtective Day Lotion

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51861-060PROTECTIVE DAY (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE) LOTION [USANA HEALTH SCIENCES, INC.]5Legacy NDC20231216_401e53ee-d69d-4ba6-8cbd-8ebfbf6c606e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51861-060-00518610060001 BOTTLE in 1 CARTON (51861-060-00) > 30 mL in 1 BOTTLE1 bottle2017-08-010000-00-00NoNoCurrent