FDA.reportPublic FDA data

Zylast Antiseptic K

Product NDC
57362-468
11-digit product format
573620468
Labeler code
57362
Product ID
57362-468_050d6202-97f5-7c43-e063-6294a90a1d74
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Innovative Biodefense
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zylast Antiseptic K
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046442Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
84766b3b-915c-b604-e053-2a91aa0a672cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
57362-468-002023-11-12Zylast Antiseptic Lotion K
57362-468-032023-11-12Zylast Antiseptic Lotion K
57362-468-042023-11-12Zylast Antiseptic Lotion K
57362-468-052023-11-12Zylast Antiseptic Lotion K
57362-468-002023-01-30Zylast Antiseptic Lotion K
57362-468-032023-01-30Zylast Antiseptic Lotion K
57362-468-042023-01-30Zylast Antiseptic Lotion K
57362-468-052023-01-30Zylast Antiseptic Lotion K
57362-468-002021-11-03Zylast Antiseptic Lotion K
57362-468-032021-11-03Zylast Antiseptic Lotion K
57362-468-052021-11-03Zylast Antiseptic Lotion K
57362-468-002021-01-29Zylast Antiseptic Lotion K
57362-468-032021-01-29Zylast Antiseptic Lotion K
57362-468-052021-01-29Zylast Antiseptic Lotion K

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57362-468-00Zylast Antiseptic K59.1 mL in 1 BOTTLE, DISPENSINGLOTION59.13
57362-468-03Zylast Antiseptic K236.6 mL in 1 BOTTLE, PUMPLOTION236.63
57362-468-04Zylast Antiseptic K14.8 mL in 1 TUBELOTION14.83
57362-468-05Zylast Antiseptic K1000 mL in 1 CARTRIDGELOTION10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57362-468ZYLAST ANTISEPTIC K (BENZALKONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]3Current NDC, Legacy NDC, 4 package rows20231113_84766b3b-915c-b604-e053-2a91aa0a672c.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
Zylast Antiseptic KBENZALKONIUM CHLORIDEInnovative Biodefense84766b3b-915c-b604-e053-2a91aa0a672c2023-01-01WarningsExact identifier
ndc (product): 57362-468

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046442benzalkonium chloride 0.13 % Topical LotionPSN84766b3b-915c-b604-e053-2a91aa0a672c3
1046442benzalkonium chloride 1.3 MG/ML Topical LotionSCD84766b3b-915c-b604-e053-2a91aa0a672c3
1046442benzalkonium chloride 0.13 % Topical LotionSY84766b3b-915c-b604-e053-2a91aa0a672c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57362-468-005736204680059.1 mL in 1 BOTTLE, DISPENSING (57362-468-00) 59.1 ml2020-01-010000-00-00NoNoCurrent
57362-468-0357362046803236.6 mL in 1 BOTTLE, PUMP (57362-468-03) 236.6 ml2020-01-010000-00-00NoNoCurrent
57362-468-045736204680414.8 mL in 1 TUBE (57362-468-04) 14.8 ml2020-01-010000-00-00NoNoCurrent
57362-468-05573620468051000 mL in 1 CARTRIDGE (57362-468-05) 1000 ml2020-01-010000-00-00NoNoCurrent