HANDS FIRST TM

Product NDC: 81858-021
11-digit product format: 818580021
Labeler code: 81858
Product ID: 81858-021_b9a6a16f-4f94-434f-9ec8-999ac95781f5
Type: HUMAN OTC DRUG
Nonproprietary name: benzalkonium chloride
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Hands First, LLC.
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-05-07
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	81858-021		I	Inactivated by FDA	2026-11-12
excluded package	package	81858-021	81858-021-01	I	Inactivated by FDA	2026-11-12
excluded package	package	81858-021	81858-021-02	I	Inactivated by FDA	2026-11-12
excluded package	package	81858-021	81858-021-04	I	Inactivated by FDA	2026-11-12
excluded package	package	81858-021	81858-021-06	I	Inactivated by FDA	2026-11-12
excluded package	package	81858-021	81858-021-08	I	Inactivated by FDA	2026-11-12
excluded package	package	81858-021	81858-021-12	I	Inactivated by FDA	2026-11-12
excluded package	package	81858-021	81858-021-16	I	Inactivated by FDA	2026-11-12
excluded package	package	81858-021	81858-021-32	I	Inactivated by FDA	2026-11-12
excluded package	package	81858-021	81858-021-64	I	Inactivated by FDA	2026-11-12

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 3 · 150 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81858-021-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81858-021-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81858-021-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81858-021-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81858-021-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81858-021-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81858-021-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81858-021-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81858-021-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81858-021-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81858-021-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81858-021-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81858-021-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81858-021-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81858-021-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81858-021-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81858-021-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81858-021-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81858-021-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81858-021-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81858-021-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81858-021-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81858-021-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81858-021-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81858-021-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81858-021-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81858-021-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81858-021-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81858-021-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81858-021-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81858-021-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81858-021-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81858-021-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81858-021-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81858-021-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81858-021-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81858-021-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81858-021-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81858-021-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81858-021-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81858-021-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81858-021-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81858-021-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81858-021-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81858-021-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81858-021-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81858-021-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81858-021-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81858-021-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81858-021-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81858-021-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81858-021-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81858-021-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81858-021-12	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
81858-021-01	Drug Facts
81858-021-02	Drug Facts
81858-021-04	Drug Facts
81858-021-06	Drug Facts
81858-021-08	Drug Facts
81858-021-12	Drug Facts
81858-021-16	Drug Facts
81858-021-32	Drug Facts
81858-021-64	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81858-021-01	HANDS FIRST TM	3785 mL in 1 BOTTLE	SOLUTION	3785	1
81858-021-02	HANDS FIRST TM	59 mL in 1 BOTTLE	SOLUTION	59	1
81858-021-04	HANDS FIRST TM	118 mL in 1 BOTTLE	SOLUTION	118	1
81858-021-06	HANDS FIRST TM	177 mL in 1 BOTTLE	SOLUTION	177	1
81858-021-08	HANDS FIRST TM	236 mL in 1 BOTTLE	SOLUTION	236	1
81858-021-12	HANDS FIRST TM	354 mL in 1 BOTTLE	SOLUTION	354	1
81858-021-16	HANDS FIRST TM	473 mL in 1 BOTTLE	SOLUTION	473	1
81858-021-32	HANDS FIRST TM	946 mL in 1 BOTTLE	SOLUTION	946	1
81858-021-64	HANDS FIRST TM	1892 mL in 1 BOTTLE	SOLUTION	1892	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81858-021	HANDS FIRST TM (BENZALKONIUM CHLORIDE) SOLUTION [HANDS FIRST, LLC.]	1	Legacy NDC, 9 package rows	20210513_d64e5183-07b2-4254-967f-289b52a9ff8e.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
1020365	benzalkonium chloride 0.13 % Topical Foam	PSN	d64e5183-07b2-4254-967f-289b52a9ff8e	1
1020365	benzalkonium chloride 1.3 MG/ML Topical Foam	SCD	d64e5183-07b2-4254-967f-289b52a9ff8e	1
1020365	benzalkonium chloride 0.13 % Topical Foam	SY	d64e5183-07b2-4254-967f-289b52a9ff8e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81858-021-01	81858002101	3785 mL in 1 BOTTLE (81858-021-01)	3785 ml	2021-05-07	0000-00-00	No	No	Current
81858-021-02	81858002102	59 mL in 1 BOTTLE (81858-021-02)	59 ml	2021-05-07	0000-00-00	No	No	Current
81858-021-04	81858002104	118 mL in 1 BOTTLE (81858-021-04)	118 ml	2021-05-07	0000-00-00	No	No	Current
81858-021-06	81858002106	177 mL in 1 BOTTLE (81858-021-06)	177 ml	2021-05-07	0000-00-00	No	No	Current
81858-021-08	81858002108	236 mL in 1 BOTTLE (81858-021-08)	236 ml	2021-05-07	0000-00-00	No	No	Current
81858-021-12	81858002112	354 mL in 1 BOTTLE (81858-021-12)	354 ml	2021-05-07	0000-00-00	No	No	Current
81858-021-16	81858002116	473 mL in 1 BOTTLE (81858-021-16)	473 ml	2021-05-07	0000-00-00	No	No	Current
81858-021-32	81858002132	946 mL in 1 BOTTLE (81858-021-32)	946 ml	2021-05-07	0000-00-00	No	No	Current
81858-021-64	81858002164	1892 mL in 1 BOTTLE (81858-021-64)	1892 ml	2021-05-07	0000-00-00	No	No	Current