FDA.reportPublic FDA data

UNNAPLAST

Product NDC
28691-2500
Requested package NDC
28691-2500-2
11-digit product format
286912500
Labeler code
28691
Product ID
28691-2500_9653ea67-bbc3-43cb-b901-96727f50e436
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
PASTE
Route
TOPICAL
Labeler
Pharmaplast SAE
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
5 mg/cm2
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage28691-250028691-2500-2DDiscontinued by firm2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZUNNAPLAST (ZINC OXIDE) PASTE [PHARMAPLAST SAE]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZUNNAPLAST (ZINC OXIDE) PASTE [PHARMAPLAST SAE]1
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XUNNAPLAST (ZINC OXIDE) PASTE [PHARMAPLAST SAE]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUNNAPLAST (ZINC OXIDE) PASTE [PHARMAPLAST SAE]1
WATERINACTIVE INGREDIENT059QF0KO0RUNNAPLAST (ZINC OXIDE) PASTE [PHARMAPLAST SAE]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
28691-2500-2286912500021 POUCH in 1 BOX (28691-2500-2) > 9140 cm2 in 1 POUCH1 pouch2014-01-010000-00-00NoNoCurrent