FDA.reportPublic FDA data

ANTI-BACTERIAL DOUGH

Product NDC
78048-016
Requested package NDC
78048-016-10
11-digit product format
780480016
Labeler code
78048
Product ID
78048-016_d3ccdeb4-5152-0c2e-e053-2a95a90ae8d4
Type
HUMAN OTC DRUG
Nonproprietary name
ANTI-BACTERIAL DOUGH
Dosage form
GEL
Route
TOPICAL
Labeler
Dongguan City Dexu Toys Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-23
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100g
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 packagepackage78048-01678048-016-10IInactivated by FDA2026-10-05

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
78048-016-0178048-016 ANTI-BACTERIAL DOUGH
78048-016-0278048-016 ANTI-BACTERIAL DOUGH
78048-016-0378048-016 ANTI-BACTERIAL DOUGH
78048-016-0478048-016 ANTI-BACTERIAL DOUGH
78048-016-0578048-016 ANTI-BACTERIAL DOUGH
78048-016-0678048-016 ANTI-BACTERIAL DOUGH
78048-016-0778048-016 ANTI-BACTERIAL DOUGH
78048-016-0878048-016 ANTI-BACTERIAL DOUGH
78048-016-0978048-016 ANTI-BACTERIAL DOUGH
78048-016-1078048-016 ANTI-BACTERIAL DOUGH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78048-016-01ANTI-BACTERIAL DOUGH29 g in 1 BOXGEL291
78048-016-02ANTI-BACTERIAL DOUGH57 g in 1 BOXGEL571
78048-016-03ANTI-BACTERIAL DOUGH85 g in 1 BOXGEL851
78048-016-04ANTI-BACTERIAL DOUGH114 g in 1 BOXGEL1141
78048-016-05ANTI-BACTERIAL DOUGH142 g in 1 BOXGEL1421
78048-016-06ANTI-BACTERIAL DOUGH170 g in 1 BOXGEL1701
78048-016-07ANTI-BACTERIAL DOUGH199 g in 1 BOXGEL1991
78048-016-08ANTI-BACTERIAL DOUGH227 g in 1 BOXGEL2271
78048-016-09ANTI-BACTERIAL DOUGH255 g in 1 BOXGEL2551
78048-016-10ANTI-BACTERIAL DOUGH284 g in 1 BOXGEL2841

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78048-016ANTI-BACTERIAL DOUGH GEL [DONGGUAN CITY DEXU TOYS CO., LTD.]1Legacy NDC, 10 package rows20211225_d3ccdea4-daf0-d30f-e053-2995a90a0048.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78048-016-1078048001610284 g in 1 BOX (78048-016-10) 284 g2021-03-300000-00-00NoNoCurrent