FDA.reportPublic FDA data

Antiseptic Towelette

Product NDC
0498-0501
Requested package NDC
0498-0501-34
11-digit product format
004980501
Labeler code
0498
Product ID
0498-0501_f0ecb90e-fbd0-a39e-e053-2995a90a087c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Honeywell Safety Products USA, Inc
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-12-21
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 packagepackage0498-05010498-0501-34DDiscontinued by firm2026-08-11

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0498-0501-004314 First Aid Kit1.4 mL in 1 PACKETLIQUID1.4 mL1.3 mg in 1mL1
0498-0501-004315 First Aid Kit1.4 mL in 1 PACKETLIQUID7 mL1.3 mg in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-05014314 FIRST AID KIT (4314 FIRST AID) KIT 4315 FIRST AID KIT (4315 FIRST AID) KIT [HONEYWELL SAFETY PRODUCTS USA, INC.]1Legacy NDC20190512_889424aa-17a4-34d2-e053-2995a90a12f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN889424aa-17a4-34d2-e053-2995a90a12f51
1038558benzalkonium chloride 0.13 % Medicated PadPSN889424aa-17a4-34d2-e053-2995a90a12f51
581660ethanol 62 % Topical GelPSN889424aa-17a4-34d2-e053-2995a90a12f51
1053173water 98.6 % Ophthalmic Irrigation SolutionPSN889424aa-17a4-34d2-e053-2995a90a12f51
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD889424aa-17a4-34d2-e053-2995a90a12f51
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD889424aa-17a4-34d2-e053-2995a90a12f51
581660ethanol 0.62 ML/ML Topical GelSCD889424aa-17a4-34d2-e053-2995a90a12f51
1053173water 986 MG/ML Ophthalmic Irrigation SolutionSCD889424aa-17a4-34d2-e053-2995a90a12f51
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY889424aa-17a4-34d2-e053-2995a90a12f51
1038558benzalkonium chloride 0.13 % Topical ClothSY889424aa-17a4-34d2-e053-2995a90a12f51
1038558benzalkonium chloride 0.13 % Topical SwabSY889424aa-17a4-34d2-e053-2995a90a12f51
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY889424aa-17a4-34d2-e053-2995a90a12f51
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY889424aa-17a4-34d2-e053-2995a90a12f51
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY889424aa-17a4-34d2-e053-2995a90a12f51
581660ethanol 62 % Topical GelSY889424aa-17a4-34d2-e053-2995a90a12f51
1053173water 98.577 % Ophthalmic Irrigation SolutionSY889424aa-17a4-34d2-e053-2995a90a12f51
1053173water 98.6 % Ophthalmic Irrigation SolutionSY889424aa-17a4-34d2-e053-2995a90a12f51
1053173water 98.6 ML per 100 ML Ophthalmic Irrigation SolutionSY889424aa-17a4-34d2-e053-2995a90a12f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0498-0501-340049805013410 PACKET in 1 BOX, UNIT-DOSE (0498-0501-34) > 1.4 mL in 1 PACKET10 packet2017-12-210000-00-00NoNoCurrent