FDA.reportPublic FDA data

DigiSan E

Product NDC
47593-404
Requested package NDC
47593-404-41
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf0f0e43-953f-4a5c-a529-85bb31019b6fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-404-30DigiSan E207 mL in 1 BOTTLE, PLASTICSOLUTION2074
47593-404-41DigiSan E750 mL in 1 BOTTLE, PLASTICSOLUTION7504
47593-404-59DigiSan E1250 mL in 1 BOTTLE, PLASTICSOLUTION12504

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7DIGISAN E FOAM HAND SANITIZER (ANTISEPTIC HANDWASH) SOLUTION [ECOLAB INC.]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YDIGISAN E FOAM HAND SANITIZER (ANTISEPTIC HANDWASH) SOLUTION [ECOLAB INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-404DIGISAN E (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]4Current NDC, Legacy NDC, 3 package rows20240330_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DigiSan EBENZALKONIUM CHLORIDEEcolab Inc.bf0f0e43-953f-4a5c-a529-85bb31019b6f2024-03-28WarningsExact identifier
ndc (package): 47593-404-41
ndc (product): 47593-404
ndc11 (package): 47593040441

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSNbf0f0e43-953f-4a5c-a529-85bb31019b6f4
1038834DigiSan E Foam 0.1 % Topical FoamPSNbf0f0e43-953f-4a5c-a529-85bb31019b6f4
1038834benzalkonium chloride 1 MG/ML Topical Foam [DigiSan E Foam]SBDbf0f0e43-953f-4a5c-a529-85bb31019b6f4
1038799benzalkonium chloride 1 MG/ML Topical FoamSCDbf0f0e43-953f-4a5c-a529-85bb31019b6f4
1038799benzalkonium chloride 0.1 % Topical FoamSYbf0f0e43-953f-4a5c-a529-85bb31019b6f4
1038834DigiSan E Foam 0.1 % Topical FoamSYbf0f0e43-953f-4a5c-a529-85bb31019b6f4
1038834DigiSan E Foam 1 MG/ML Topical FoamSYbf0f0e43-953f-4a5c-a529-85bb31019b6f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47593-404-4147593040441750 mL in 1 BOTTLE, PLASTIC (47593-404-41) 750 ml2003-11-040000-00-00NoNoCurrent