SOFTIS

Product NDC: 77824-004
Requested package NDC: 77824-004-01
11-digit product format: 778240004
Labeler code: 77824
Product ID: 77824-004_aee6d60e-d736-2375-e053-2a95a90acc8e
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE, POLYAMINOPROPIL BIGUANIDE
Dosage form: CLOTH
Route: TOPICAL
Labeler: Betone, S.A de C.V.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-30
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE; POLYAMINOPROPYL BIGUANIDE
Active strength: 0 g/100mL; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	77824-004	77824-004-01	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 · 18 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
77824-004-01	2022-01-28	C162847	48780-1	d6a99b39-c922-a426-e053-dadaa90af4c2	BETONE- Toallitas Jabón

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77824-004-01	SOFTIS	150 mL in 1 POUCH	CLOTH	150		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77824-004	SOFTIS (BENZALKONIUM CHLORIDE, POLYAMINOPROPIL BIGUANIDE) CLOTH [BETONE, S.A DE C.V.]	2	Legacy NDC, 1 package rows	20200910_a9dcf681-1675-7ad9-e053-2995a90a19f7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE
DT9D8Z79ET	POLYAMINOPROPYL BIGUANIDE	133029-32-0	POLYAMINOPROPYL BIGUANIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2375049	benzalkonium chloride 0.12 % / polyaminopropyl biguanide 0.5 % Medicated Pad	PSN	a9dcf681-1675-7ad9-e053-2995a90a19f7	2
2375049	benzalkonium chloride 1.2 MG/ML / polyaminopropyl biguanide 5 MG/ML Medicated Pad	SCD	a9dcf681-1675-7ad9-e053-2995a90a19f7	2
2375049	benzalkonium chloride 0.12 % / polyaminopropyl biguanide 0.5 % Medicated Pad	SY	a9dcf681-1675-7ad9-e053-2995a90a19f7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77824-004-01	77824000401	150 mL in 1 POUCH (77824-004-01)	150 ml	2020-03-30	0000-00-00	No	No	Current