DuraShield Fragrance Free Hand Sanitizer

Product NDC
78235-012
Requested package NDC
78235-012-06
11-digit product format
782350012
Labeler code
78235
Product ID
78235-012_33272bda-35d0-4d8b-b6d5-12f920da4df4
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride lotion
Dosage form
LOTION
Route
TOPICAL
Labeler
CK Polymers LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-10-06
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 mg/mL
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 packagepackage78235-01278235-012-06IInactivated 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 · 17 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…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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
78235-012-01DuraShield Fragrance Free Hand Sanitizer3785 mL in 1 JUGLOTION37854
78235-012-02DuraShield Fragrance Free Hand Sanitizer208175 mL in 1 DRUMLOTION2081754
78235-012-03DuraShield Fragrance Free Hand Sanitizer18927.1 mL in 1 CONTAINERLOTION18927.14
78235-012-04DuraShield Fragrance Free Hand Sanitizer1249050 mL in 1 CONTAINERLOTION12490504
78235-012-05DuraShield Fragrance Free Hand Sanitizer1040875 mL in 1 CONTAINERLOTION10408754
78235-012-06DuraShield Fragrance Free Hand Sanitizer60 mL in 1 CONTAINERLOTION604
78235-012-07DuraShield Fragrance Free Hand Sanitizer118 mL in 1 CONTAINERLOTION1184
78235-012-08DuraShield Fragrance Free Hand Sanitizer237 mL in 1 CONTAINERLOTION2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78235-012DURASHIELD FRAGRANCE FREE HAND SANITIZER (BENZALKONIUM CHLORIDE LOTION) LOTION [CK POLYMERS LLC]4Legacy NDC, 8 package rows20220421_f2fee473-d3c0-4dfe-94dd-6314f5d49dd0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78235-012-067823500120660 mL in 1 CONTAINER (78235-012-06) 60 ml2020-10-090000-00-00NoNoCurrent