FDA.reportPublic FDA data

Xpect Antiseptic

Product NDC
42961-227
11-digit product format
429610227
Labeler code
42961
Product ID
42961-227_d7e7ee0e-159b-4040-ad6b-f40f0c639915
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
Cintas Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-19
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9a31a11-e80f-4ded-ad0a-34f93b01557eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42961-227-01Xpect Antiseptic59.1 mL in 1 BOTTLE, SPRAYSPRAY59.14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-227XPECT ANTISEPTIC (BENZALKONIUM CHLORIDE) SPRAY [CINTAS CORPORATION]3Current NDC, 1 package rows20241228_d9a31a11-e80f-4ded-ad0a-34f93b01557e.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 54 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen Peroxide1169 HYDROGEN PEROXIDE SPRAYDynarex Corporation11854afb-db97-5a43-e063-6394a90aa39c2025-11-19WarningsExact identifier
application number: M003
Sani-SpritzALCOHOLABC Compounding Co., Inc.ac88c676-c396-4fb8-9e5c-77c726ed69d82025-11-19WarningsExact identifier
application number: M003
Osceola Supply Inc 6176CHLOROXYLENOLOSCEOLA SUPPLY, INC.a7dcc6b1-655d-41b3-ab97-913bc4aae01f2025-11-19WarningsExact identifier
application number: M003
AMERISILKBZKSHIELD LINE LLC43f9775c-0448-243e-e063-6294a90a9e222025-11-19WarningsExact identifier
application number: M003
Antibacterial Foamy Mango High Foaming Antiseptic Hand and Body WashCHLOROXYLENOLCarpet Rentals, Inc.a95b4d71-119e-4c3b-a280-09bd4533252b2025-11-18WarningsExact identifier
application number: M003
PetroleumWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)684ac03a-f9b1-412d-8ce5-819ca132dc342025-11-17WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD435fd382-d2f5-b07f-e063-6294a90a7d8a2025-11-14WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD43401653-b260-e86d-e063-6294a90abb3f2025-11-13WarningsExact identifier
application number: M003
CVS Health Isopropyl Rubbing Alcohol PadsISOPROPYL ALCOHOLCVS Healthc8d4f3b3-166c-2411-e053-2a95a90abb4a2025-11-12WarningsExact identifier
application number: M003
PetroleumWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)e3100877-6261-4502-8db8-d8ae3af6cd792025-11-12WarningsExact identifier
application number: M003
PetroleumWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)c65ddc74-4666-457d-91bd-138143446bbe2025-11-12WarningsExact identifier
application number: M003
Dr Lift Antibacterial Hand SanitizerETHYL ALCOHOLSpa de Soleilaba006cd-18db-e42f-e053-2995a90a46072025-11-12WarningsExact identifier
application number: M003
Recovery Antiseptic Skin PrepCHLOROXYLENOLPURKLENZ FORMULATIONS INC.94c5ea07-6bdb-42c6-8ce0-0d0711bd70362025-11-12WarningsExact identifier
application number: M003
PurKlenzCHLOROXYLENOLPurKlenz Formulations Inc.9f1223a8-a256-46f0-b01d-01b32ca09d482025-11-12WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Lemon SorbetALCOHOLShenzhen Lantern Scicence Co.,Ltd.434d3071-802b-f598-e063-6394a90a622d2025-11-11WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Strawberry ShortcakeALCOHOLShenzhen Lantern Scicence Co.,Ltd.434d5f7c-f84d-d6f5-e063-6294a90aa6fe2025-11-11WarningsExact identifier
application number: M003
Walgreens Hand Sanitizer PearALCOHOLShenzhen Lantern Scicence Co.,Ltd.434ddef3-fe48-138d-e063-6394a90afc912025-11-11WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd9884b7-6df3-5ece-e053-2a95a90ab20e2025-11-11WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd8643ef-dc83-8bc1-e053-2995a90a007b2025-11-11WarningsExact identifier
application number: M003
Betadine Solution SwabsticksPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.0707b259-52a4-4ae6-b176-d093865906e72025-11-11WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42961-227-014296102270159.1 mL in 1 BOTTLE, SPRAY (42961-227-01) 59.1 ml2023-04-19NoNoCurrent