Antiseptic

Product NDC
69396-153
11-digit product format
693960153
Labeler code
69396
Product ID
69396-153_13f1a05a-30a4-34da-e063-6394a90a8b6a
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride 0.13%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA, LLC.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-18
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 g/L
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
Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 g/L

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
1039012Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
13f1c70f-3b44-8eef-e063-6294a90af634Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-153-02Antiseptic0.0591 L in 1 BOTTLE, SPRAYSPRAY0.05911

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-153ANTISEPTIC (BENZALKONIUM CHLORIDE 0.13%) SPRAY [TRIFECTA PHARMACEUTICALS USA, LLC.]1Current NDC, 1 package rows20240322_13f1c70f-3b44-8eef-e063-6294a90af634.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSN13f1c70f-3b44-8eef-e063-6294a90af6341
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCD13f1c70f-3b44-8eef-e063-6294a90af6341
1039012benzalkonium chloride 0.13 % Topical SpraySY13f1c70f-3b44-8eef-e063-6294a90af6341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69396-153-0269396015302.0591 L in 1 BOTTLE, SPRAY (69396-153-02) 2024-03-18NoNoCurrent