DuraShield Original Scent Hand Sanitizer

Product NDC
78235-011
Requested package NDC
78235-011-03
11-digit product format
782350011
Labeler code
78235
Product ID
78235-011_3945b000-e039-4b40-a865-61243ae42aa6
Type
HUMAN OTC DRUG
Nonproprietary name
Safe and Silky Fragrance HS
Dosage form
LOTION
Route
TOPICAL
Labeler
CK Polymers LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-10-08
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 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 packagepackage78235-01178235-011-03IInactivated 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
78235-011-01DuraShield Original Scent Hand Sanitizer3780 mL in 1 JUGLOTION37806
78235-011-02DuraShield Original Scent Hand Sanitizer208190 mL in 1 DRUMLOTION2081906
78235-011-03DuraShield Original Scent Hand Sanitizer18927.1 mL in 1 CONTAINERLOTION18927.16
78235-011-04DuraShield Original Scent Hand Sanitizer1249190 mL in 1 CONTAINERLOTION12491906
78235-011-05DuraShield Original Scent Hand Sanitizer1040990 mL in 1 CONTAINERLOTION10409906
78235-011-06DuraShield Original Scent Hand Sanitizer60 mL in 1 BOTTLELOTION606
78235-011-07DuraShield Original Scent Hand Sanitizer120 mL in 1 BOTTLELOTION1206
78235-011-08DuraShield Original Scent Hand Sanitizer240 mL in 1 BOTTLELOTION2406

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78235-011DURASHIELD ORIGINAL SCENT HAND SANITIZER (SAFE AND SILKY FRAGRANCE HS) LOTION [CK POLYMERS LLC]6Legacy NDC, 8 package rows20220421_47c64b60-8400-4e3d-a361-be3026a2374d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046442benzalkonium chloride 0.13 % Topical LotionPSN47c64b60-8400-4e3d-a361-be3026a2374d6
1046442benzalkonium chloride 1.3 MG/ML Topical LotionSCD47c64b60-8400-4e3d-a361-be3026a2374d6
1046442benzalkonium chloride 0.13 % Topical LotionSY47c64b60-8400-4e3d-a361-be3026a2374d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78235-011-037823500110318927.1 mL in 1 CONTAINER (78235-011-03) 18927.1 ml2020-10-080000-00-00NoNoCurrent