FDA.reportPublic FDA data

Anitiseptic Sanitizing Wipes

Product NDC
78601-002
Requested package NDC
78601-002-01
11-digit product format
786010002
Labeler code
78601
Product ID
78601-002_afc95af3-4b2c-1d7b-e053-2995a90a8ec8
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Jiaxing Qinya Sanitary Products Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-05
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100g
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 packagepackage78601-00278601-002-01IInactivated by FDA2026-10-12

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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
78601-002-0178601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE
78601-002-0278601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE
78601-002-0378601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE
78601-002-0478601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE
78601-002-0578601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE
78601-002-0678601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE
78601-002-0778601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE
78601-002-0878601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE
78601-002-0978601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE
78601-002-1078601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE
78601-002-1178601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78601-002-01Anitiseptic Sanitizing Wipes10 in 1 BAGCLOTH102
78601-002-01Anitiseptic Sanitizing Wipes0.005265 g in 1 POUCHCLOTH0.0052652
78601-002-02Anitiseptic Sanitizing Wipes900 in 1 BAGCLOTH9002
78601-002-02Anitiseptic Sanitizing Wipes4.7385 g in 1 POUCHCLOTH4.73852
78601-002-03Anitiseptic Sanitizing Wipes6.318 g in 1 POUCHCLOTH6.3182
78601-002-03Anitiseptic Sanitizing Wipes1200 in 1 BAGCLOTH12002
78601-002-04Anitiseptic Sanitizing Wipes180 in 1 BAGCLOTH1802
78601-002-04Anitiseptic Sanitizing Wipes0.09477 g in 1 POUCHCLOTH0.094772
78601-002-05Anitiseptic Sanitizing Wipes0.131625 g in 1 POUCHCLOTH0.1316252
78601-002-05Anitiseptic Sanitizing Wipes250 in 1 BAGCLOTH2502
78601-002-06Anitiseptic Sanitizing Wipes80 in 1 BAGCLOTH802
78601-002-06Anitiseptic Sanitizing Wipes0.04212 g in 1 POUCHCLOTH0.042122
78601-002-07Anitiseptic Sanitizing Wipes0.4212 g in 1 POUCHCLOTH0.42122
78601-002-07Anitiseptic Sanitizing Wipes800 in 1 BAGCLOTH8002
78601-002-08Anitiseptic Sanitizing Wipes180 in 1 PAILCLOTH1802
78601-002-08Anitiseptic Sanitizing Wipes0.09477 g in 1 POUCHCLOTH0.094772
78601-002-09Anitiseptic Sanitizing Wipes1.31625 g in 1 POUCHCLOTH1.316252
78601-002-09Anitiseptic Sanitizing Wipes250 in 1 PAILCLOTH2502
78601-002-10Anitiseptic Sanitizing Wipes20 in 1 BAGCLOTH202
78601-002-10Anitiseptic Sanitizing Wipes0.01053 g in 1 POUCHCLOTH0.010532
78601-002-11Anitiseptic Sanitizing Wipes0.08424 g in 1 POUCHCLOTH0.084242
78601-002-11Anitiseptic Sanitizing Wipes160 in 1 PAILCLOTH1602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78601-002ANITISEPTIC SANITIZING WIPES (BENZALKONIUM CHLORIDE) CLOTH [JIAXING QINYA SANITARY PRODUCTS CO., LTD.]2Legacy NDC, 22 package rows20200921_a74c3488-696f-b3a6-e053-2a95a90a9f09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNa74c3488-696f-b3a6-e053-2a95a90a9f092
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDa74c3488-696f-b3a6-e053-2a95a90a9f092
1038558benzalkonium chloride 0.13 % Topical ClothSYa74c3488-696f-b3a6-e053-2a95a90a9f092
1038558benzalkonium chloride 0.13 % Topical SwabSYa74c3488-696f-b3a6-e053-2a95a90a9f092
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYa74c3488-696f-b3a6-e053-2a95a90a9f092
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYa74c3488-696f-b3a6-e053-2a95a90a9f092
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYa74c3488-696f-b3a6-e053-2a95a90a9f092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78601-002-017860100020110 POUCH in 1 BAG (78601-002-01) > .005265 g in 1 POUCH10 pouch2020-06-050000-00-00NoNoCurrent