Nilaqua ANTISEPTIC HAND SANITIZER FOAM

Product NDC: 80349-102
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80349-102		I	Inactivated by FDA	2026-10-05
excluded package	package	80349-102	80349-102-01	I	Inactivated by FDA	2026-10-05
excluded package	package	80349-102	80349-102-02	I	Inactivated by FDA	2026-10-05
excluded package	package	80349-102	80349-102-03	I	Inactivated by FDA	2026-10-05
excluded package	package	80349-102	80349-102-04	I	Inactivated by FDA	2026-10-05
excluded package	package	80349-102	80349-102-05	I	Inactivated by FDA	2026-10-05
excluded package	package	80349-102	80349-102-06	I	Inactivated by FDA	2026-10-05
excluded package	package	80349-102	80349-102-07	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 3 · 144 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	80349-102-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80349-102-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80349-102-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80349-102-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80349-102-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80349-102-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80349-102-02	`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	80349-102-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80349-102-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80349-102-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80349-102-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80349-102-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80349-102-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80349-102-02	`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	80349-102-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80349-102-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80349-102-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80349-102-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80349-102-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80349-102-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80349-102-02	`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	80349-102-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80349-102-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80349-102-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80349-102-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80349-102-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80349-102-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80349-102-02	`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	80349-102-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80349-102-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80349-102-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80349-102-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80349-102-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80349-102-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80349-102-02	`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	80349-102-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80349-102-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80349-102-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80349-102-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80349-102-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80349-102-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80349-102-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80349-102-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80349-102-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80349-102-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80349-102-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80349-102-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80349-102-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80349-102-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80349-102-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80349-102-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80349-102-06	`ed331223b511…`	`672a5bd82f5f…`

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
80349-102-01	Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-02	Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-03	Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-04	Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-05	Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-06	Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-07	Nilaqua ® ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80349-102-01	Nilaqua ANTISEPTIC HAND SANITIZER FOAM	55 mL in 1 BOTTLE, PUMP	LIQUID	55	1
80349-102-02	Nilaqua ANTISEPTIC HAND SANITIZER FOAM	100 mL in 1 BOTTLE, SPRAY	LIQUID	100	1
80349-102-03	Nilaqua ANTISEPTIC HAND SANITIZER FOAM	200 mL in 1 BOTTLE, PUMP	LIQUID	200	1
80349-102-04	Nilaqua ANTISEPTIC HAND SANITIZER FOAM	500 mL in 1 BOTTLE, PUMP	LIQUID	500	1
80349-102-05	Nilaqua ANTISEPTIC HAND SANITIZER FOAM	800 mL in 1 BOTTLE, PUMP	LIQUID	800	1
80349-102-06	Nilaqua ANTISEPTIC HAND SANITIZER FOAM	1000 mL in 1 BOTTLE, PUMP	LIQUID	1000	1
80349-102-07	Nilaqua ANTISEPTIC HAND SANITIZER FOAM	5000 mL in 1 CONTAINER	LIQUID	5000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80349-102	NILAQUA ANTISEPTIC HAND SANITIZER FOAM (BENZALKONIUM CHLORIDE) LIQUID [WATERLESS LIMITED]	1	Legacy NDC, 7 package rows	20201117_cd451804-1532-46bb-868e-641b4561b1db.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
2464108	benzalkonium chloride 0.8 % Topical Foam	PSN	cd451804-1532-46bb-868e-641b4561b1db	1
2464108	benzalkonium chloride 8 MG/ML Topical Foam	SCD	cd451804-1532-46bb-868e-641b4561b1db	1
2464108	benzalkonium chloride 0.8 % Topical Foam	SY	cd451804-1532-46bb-868e-641b4561b1db	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80349-102-01	80349010201	55 mL in 1 BOTTLE, PUMP (80349-102-01)	55 ml	2020-01-08	0000-00-00	No	No	Current
80349-102-02	80349010202	100 mL in 1 BOTTLE, SPRAY (80349-102-02)	100 ml	2020-01-08	0000-00-00	No	No	Current
80349-102-03	80349010203	200 mL in 1 BOTTLE, PUMP (80349-102-03)	200 ml	2020-01-08	0000-00-00	No	No	Current
80349-102-04	80349010204	500 mL in 1 BOTTLE, PUMP (80349-102-04)	500 ml	2020-01-08	0000-00-00	No	No	Current
80349-102-05	80349010205	800 mL in 1 BOTTLE, PUMP (80349-102-05)	800 ml	2020-01-08	0000-00-00	No	No	Current
80349-102-06	80349010206	1000 mL in 1 BOTTLE, PUMP (80349-102-06)	1000 ml	2020-01-08	0000-00-00	No	No	Current
80349-102-07	80349010207	5000 mL in 1 CONTAINER (80349-102-07)	5000 ml	2020-01-08	0000-00-00	No	No	Current