Nilaqua ANTISEPTIC HAND SANITIZER FOAM

Product NDC
80349-102
Requested package NDC
80349-102-01
11-digit product format
803490102
Labeler code
80349
Product ID
80349-102_f75a7992-f1ae-404d-88bd-bd35213e7644
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
WATERLESS LIMITED
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-01-08
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 g/100mL
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 packagepackage80349-10280349-102-01IInactivated 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 · 18 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
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.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80349-102-01Nilaqua ANTISEPTIC HAND SANITIZER FOAM55 mL in 1 BOTTLE, PUMPLIQUID551
80349-102-02Nilaqua ANTISEPTIC HAND SANITIZER FOAM100 mL in 1 BOTTLE, SPRAYLIQUID1001
80349-102-03Nilaqua ANTISEPTIC HAND SANITIZER FOAM200 mL in 1 BOTTLE, PUMPLIQUID2001
80349-102-04Nilaqua ANTISEPTIC HAND SANITIZER FOAM500 mL in 1 BOTTLE, PUMPLIQUID5001
80349-102-05Nilaqua ANTISEPTIC HAND SANITIZER FOAM800 mL in 1 BOTTLE, PUMPLIQUID8001
80349-102-06Nilaqua ANTISEPTIC HAND SANITIZER FOAM1000 mL in 1 BOTTLE, PUMPLIQUID10001
80349-102-07Nilaqua ANTISEPTIC HAND SANITIZER FOAM5000 mL in 1 CONTAINERLIQUID50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80349-102NILAQUA ANTISEPTIC HAND SANITIZER FOAM (BENZALKONIUM CHLORIDE) LIQUID [WATERLESS LIMITED]1Legacy NDC, 7 package rows20201117_cd451804-1532-46bb-868e-641b4561b1db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2464108benzalkonium chloride 0.8 % Topical FoamPSNcd451804-1532-46bb-868e-641b4561b1db1
2464108benzalkonium chloride 8 MG/ML Topical FoamSCDcd451804-1532-46bb-868e-641b4561b1db1
2464108benzalkonium chloride 0.8 % Topical FoamSYcd451804-1532-46bb-868e-641b4561b1db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80349-102-018034901020155 mL in 1 BOTTLE, PUMP (80349-102-01) 55 ml2020-01-080000-00-00NoNoCurrent