AVVA

Product NDC: 42891-4148
11-digit product format: 428914148
Labeler code: 42891
Product ID: 42891-4148_4bcdae7c-0f1a-494c-91bd-461443032e8a
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium chloride
Dosage form: GEL
Route: VAGINAL
Labeler: AVVA International LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-03-28
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 100 mg/100mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42891-4148		I	Inactivated by FDA		2026-10-16
excluded package	package	42891-4148	42891-4148-0	I	Inactivated by FDA		2026-10-16

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 · 30 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	42891-4148-0	`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	42891-4148-0	`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	42891-4148-0	`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	42891-4148-0	`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	42891-4148-0	`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	42891-4148-0	`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	42891-4148-0	`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	42891-4148-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42891-4148-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42891-4148-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42891-4148-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42891-4148-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42891-4148-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42891-4148-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42891-4148-0	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42891-4148-0	2024-01-30	C162847	48780-1	9d75b9d0-9949-f424-e053-dadaa90a57ce	Drug Facts
42891-4148-0	2020-02-02	C162847	48780-1	9d75b9d0-9949-f424-e053-dadaa90a57ce	Drug Facts
42891-4148-0	2020-01-31	C162847	48780-1	9d75b9d0-9949-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42891-4148-0	AVVA	6 in 1 BOX	GEL	6		10
42891-4148-1	AVVA	5.5 mL in 1 TUBE	GEL	5.5		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]	6
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]	6
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]	6
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]	6
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	INACTIVE INGREDIENT	ZYD53NBL45	AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42891-4148	AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]	10	Legacy NDC, 2 package rows	20220115_0aadfe31-2d94-4bae-9a6b-081c149c374d.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
1111013	benzalkonium chloride 0.1 % Vaginal Gel	PSN	0aadfe31-2d94-4bae-9a6b-081c149c374d	10
1111013	benzalkonium chloride 0.001 MG/MG Vaginal Gel	SCD	0aadfe31-2d94-4bae-9a6b-081c149c374d	10
1111013	benzalkonium chloride 0.1 % Vaginal Gel	SY	0aadfe31-2d94-4bae-9a6b-081c149c374d	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42891-4148-0	42891414800	6 TUBE in 1 BOX (42891-4148-0) > 5.5 mL in 1 TUBE (42891-4148-1)	6 tube	2012-03-28	0000-00-00	No	No	Current
42891-4148-1	42891414801	5.5 mL in 1 TUBE	5.5 ml					Historical