ESSENTIAL DAILY SUNSCREEN

Product NDC
82465-101
Requested package NDC
82465-101-14
11-digit product format
824650101
Labeler code
82465
Product ID
82465-101_db000f96-dc47-4d4d-e053-2995a90a0c21
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
ANTEDOTUM INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-04-01
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
10 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage82465-10182465-101-14DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82465-101ESSENTIAL DAILY SUNSCREEN (ZINC OXIDE) LOTION [ANTEDOTUM INC.]2Legacy NDC20241229_db000f96-dc46-4d4d-e053-2995a90a0c21.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82465-101-14824650101141 TUBE in 1 BOX (82465-101-14) > 10 mL in 1 TUBE (82465-101-13) 1 tube2022-04-010000-00-00NoNoCurrent