Harris Antibacterial Wipes Antiseptic Hand Sanitizer Wipes

Product NDC: 80510-000
Requested package NDC: 80510-000-01
11-digit product format: 805100000
Labeler code: 80510
Product ID: 80510-000_dad095a8-c0b8-d7ca-e053-2a95a90a4657
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: CLOTH
Route: TOPICAL
Labeler: TURKOSAN SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-10
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	80510-000	80510-000-01	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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 concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80510-000-01	2023-07-28	C162847	48780-1	0191ceaa-7101-198a-e063-dbdaa90aec3e	Harris Antibacterial Wipes Antiseptic Hand Sanitizer Wipes
80510-000-02	2023-07-28	C162847	48780-1	0191ceaa-7101-198a-e063-dbdaa90aec3e	Harris Antibacterial Wipes Antiseptic Hand Sanitizer Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80510-000-01	Harris Antibacterial Wipes Antiseptic Hand Sanitizer Wipes	72 in 1 POUCH	CLOTH	72	2
80510-000-01	Harris Antibacterial Wipes Antiseptic Hand Sanitizer Wipes	3.3 mL in 1 PATCH	CLOTH	3.3	2
80510-000-02	Harris Antibacterial Wipes Antiseptic Hand Sanitizer Wipes	102 in 1 POUCH	CLOTH	102	2
80510-000-02	Harris Antibacterial Wipes Antiseptic Hand Sanitizer Wipes	3.4 mL in 1 PATCH	CLOTH	3.4	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80510-000	HARRIS ANTIBACTERIAL WIPES ANTISEPTIC HAND SANITIZER WIPES (BENZALKONIUM CHLORIDE) CLOTH [TURKOSAN SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI]	2	Legacy NDC, 4 package rows	20220323_b064a87e-2214-3a52-e053-2995a90a1d8e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038558	benzalkonium chloride 0.13 % Medicated Pad	PSN	b064a87e-2214-3a52-e053-2995a90a1d8e	2
1038558	benzalkonium chloride 1.3 MG/ML Medicated Pad	SCD	b064a87e-2214-3a52-e053-2995a90a1d8e	2
1038558	benzalkonium chloride 0.13 % Topical Cloth	SY	b064a87e-2214-3a52-e053-2995a90a1d8e	2
1038558	benzalkonium chloride 0.13 % Topical Swab	SY	b064a87e-2214-3a52-e053-2995a90a1d8e	2
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Pad	SY	b064a87e-2214-3a52-e053-2995a90a1d8e	2
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Swab	SY	b064a87e-2214-3a52-e053-2995a90a1d8e	2
1038558	benzalkonium chloride 1 ML per 750 ML Topical Swab	SY	b064a87e-2214-3a52-e053-2995a90a1d8e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80510-000-01	80510000001	72 PATCH in 1 POUCH (80510-000-01) > 3.3 mL in 1 PATCH	72 patch	2020-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Harris Antibacterial Wipes Antiseptic Hand Sanitizer Wipes	TURKOSAN SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	2022-03-22	HUMAN OTC DRUG LABEL	2