DigiSan E

Product NDC: 47593-404
11-digit product format: 475930404
Labeler code: 47593
Product ID: 47593-404_eb7faa68-cdc3-497e-a994-e149ecfffacc
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium chloride
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Ecolab Inc.
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2003-11-04
Substance: BENZALKONIUM CHLORIDE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 package	package	47593-404	47593-404-30	D	Discontinued by firm		2026-08-03
excluded package	package	47593-404	47593-404-59	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	47593-404-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	47593-404-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	47593-404-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	47593-404-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	47593-404-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	47593-404-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	47593-404-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	47593-404-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	47593-404-59	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	47593-404-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	47593-404-59	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	47593-404-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	47593-404-59	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	47593-404-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	47593-404-59	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	47593-404-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	47593-404-59	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	47593-404-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	47593-404-59	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	47593-404-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	47593-404-59	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	47593-404-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	47593-404-59	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	47593-404-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: DigiSan E
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1038799	Internal RxNorm lookup
1038834	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bf0f0e43-953f-4a5c-a529-85bb31019b6f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47593-404-30	DigiSan E	207 mL in 1 BOTTLE, PLASTIC	SOLUTION	207	4
47593-404-41	DigiSan E	750 mL in 1 BOTTLE, PLASTIC	SOLUTION	750	4
47593-404-59	DigiSan E	1250 mL in 1 BOTTLE, PLASTIC	SOLUTION	1250	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	DIGISAN E FOAM HAND SANITIZER (ANTISEPTIC HANDWASH) SOLUTION [ECOLAB INC.]	1
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	DIGISAN E FOAM HAND SANITIZER (ANTISEPTIC HANDWASH) SOLUTION [ECOLAB INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47593-404	DIGISAN E (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]	4	Current NDC, Legacy NDC, 3 package rows	20240330_bf0f0e43-953f-4a5c-a529-85bb31019b6f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DigiSan E	BENZALKONIUM CHLORIDE	Ecolab Inc.	bf0f0e43-953f-4a5c-a529-85bb31019b6f	2024-03-28	Warnings	Exact identifier ndc (product): 47593-404

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
1038799	benzalkonium chloride 0.1 % Topical Foam	PSN	bf0f0e43-953f-4a5c-a529-85bb31019b6f	4
1038834	DigiSan E Foam 0.1 % Topical Foam	PSN	bf0f0e43-953f-4a5c-a529-85bb31019b6f	4
1038834	benzalkonium chloride 1 MG/ML Topical Foam [DigiSan E Foam]	SBD	bf0f0e43-953f-4a5c-a529-85bb31019b6f	4
1038799	benzalkonium chloride 1 MG/ML Topical Foam	SCD	bf0f0e43-953f-4a5c-a529-85bb31019b6f	4
1038799	benzalkonium chloride 0.1 % Topical Foam	SY	bf0f0e43-953f-4a5c-a529-85bb31019b6f	4
1038834	DigiSan E Foam 0.1 % Topical Foam	SY	bf0f0e43-953f-4a5c-a529-85bb31019b6f	4
1038834	DigiSan E Foam 1 MG/ML Topical Foam	SY	bf0f0e43-953f-4a5c-a529-85bb31019b6f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47593-404-30	47593040430	207 mL in 1 BOTTLE, PLASTIC	207 ml					Historical
47593-404-41	47593040441	750 mL in 1 BOTTLE, PLASTIC (47593-404-41)	750 ml	2003-11-04	0000-00-00	No	No	Current
47593-404-59	47593040459	1250 mL in 1 BOTTLE, PLASTIC	1250 ml					Historical