ASSURED

Product NDC: 70697-800
Requested package NDC: 70697-800-07
11-digit product format: 706970800
Labeler code: 70697
Product ID: 70697-800_d57bb3c4-9079-5727-e053-2995a90a8f94
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: SWAB
Route: TOPICAL
Labeler: INDELPA, S.A. DE C.V.
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2016-06-10
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 0 mg/100mg
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	70697-800	70697-800-07	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 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.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
70697-800-03	317f63af-9696-6bef-e054-00144ff8d46c
70697-800-04	317f63af-9696-6bef-e054-00144ff8d46c
70697-800-05	317f63af-9696-6bef-e054-00144ff8d46c
70697-800-06	317f63af-9696-6bef-e054-00144ff8d46c
70697-800-07	317f63af-9696-6bef-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70697-800-03	ASSURED	3 in 1 BAG	SWAB	3	8
70697-800-03	ASSURED	10 in 1 PACKAGE	SWAB	10	8
70697-800-04	ASSURED	40 in 1 PACKAGE	SWAB	40	8
70697-800-04	ASSURED	0.375 mg in 1 POUCH	SWAB	0.375	8
70697-800-05	ASSURED	0.375 mg in 1 POUCH	SWAB	0.375	8
70697-800-05	ASSURED	20 in 1 PACKAGE	SWAB	20	8
70697-800-06	ASSURED	2 in 1 PACKAGE	SWAB	2	8
70697-800-06	ASSURED	15 in 1 PACKAGE	SWAB	15	8
70697-800-07	ASSURED	12 in 1 CASE	SWAB	12	8
70697-800-07	ASSURED	103.2 mg in 1 POUCH	SWAB	103.2	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70697-800	ASSURED (BENZALKONIUM CHLORIDE) SWAB [INDELPA, S.A. DE C.V.]	8	Legacy NDC, 10 package rows	20220114_317f63af-9696-6bef-e054-00144ff8d46c.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
2276303	benzalkonium Cl 0.125 % Medicated Pad	PSN	317f63af-9696-6bef-e054-00144ff8d46c	8
2276303	benzalkonium chloride 1.25 MG/ML Medicated Pad	SCD	317f63af-9696-6bef-e054-00144ff8d46c	8
2276303	benzalkonium chloride 0.125 % Medicated Wipe	SY	317f63af-9696-6bef-e054-00144ff8d46c	8
2276303	benzalkonium chloride 0.125 % Topical Cloth	SY	317f63af-9696-6bef-e054-00144ff8d46c	8
2276303	benzalkonium chloride 0.125 % Topical Swab	SY	317f63af-9696-6bef-e054-00144ff8d46c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70697-800-07	70697080007	12 POUCH in 1 CASE (70697-800-07) > 103.2 mg in 1 POUCH	12 pouch	2016-06-10	0000-00-00	No	No	Current