Drunk Elephant

Product NDC
69455-463
11-digit product format
694550463
Labeler code
69455
Product ID
69455-463_8e80f47b-c919-43cf-83e3-c228f76b524d
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Drunk Elephant, LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-01-15
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
20 mg/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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69455-463IInactivated by FDA2026-10-12
excluded packagepackage69455-46369455-463-11IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69455-463-1186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69455-463-11bd6a592717d7…303034d00443…

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69455-463-11Drunk ElephantUmbra Tinte Physical Daily Defense Protection SPF-3060 mL in 1 TUBELOTION605
69455-463-11Drunk ElephantUmbra Tinte Physical Daily Defense Protection SPF-301 in 1 BOXLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69455-463DRUNK ELEPHANT UMBRA TINTE PHYSICAL DAILY DEFENSE PROTECTION SPF-30 (ZINC OXIDE) LOTION [DRUNK ELEPHANT, LLC]5Legacy NDC, 2 package rows20241204_272689a1-476c-426b-9c3e-c9fde4e1bf06.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69455-463-11694550463111 TUBE in 1 BOX (69455-463-11) > 60 mL in 1 TUBE1 tube2019-01-150000-00-00NoNoCurrent