Antiseptic

Product NDC
67777-012
11-digit product format
677770012
Labeler code
67777
Product ID
67777-012_118192ac-7174-09c5-e063-6394a90ad550
Type
HUMAN OTC DRUG
Nonproprietary name
Antiseptic Spray
Dosage form
SPRAY
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-29
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
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
118192ac-7173-09c5-e063-6394a90ad550Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-012-03Antiseptic24 in 1 CASESPRAY241
67777-012-04Antiseptic59.1 mL in 1 BOTTLE, SPRAYSPRAY59.11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-012ANTISEPTIC (ANTISEPTIC SPRAY) SPRAY [DYNAREX CORPORATION]1Current NDC, 2 package rows20240229_118192ac-7173-09c5-e063-6394a90ad550.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 85 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer with Clip 1.8ozALCOHOLNingbo Rejoice Internationalb08f2909-467d-719d-e053-2995a90a11a12025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Aloe 2ozALCOHOLNingbo Rejoice Internationalb08f2993-f166-1a0e-e053-2a95a90a93792025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Aloe 2ozALCOHOLNingbo Rejoice Internationalb08f3bf1-f55f-5c68-e053-2a95a90ac3ac2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Lavender 2ozALCOHOLNingbo Rejoice Internationalb08f6f48-796b-3b40-e053-2a95a90a75f62025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Lavender 2ozALCOHOLNingbo Rejoice Internationalb08f62b0-98dd-5aac-e053-2a95a90a6d8a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer PouchALCOHOLNingbo Rejoice Internationalb08f8faa-d9d6-5b8d-e053-2a95a90a407c2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 24ct PouchALCOHOLNingbo Rejoice Internationalb08fb47c-7241-45d3-e053-2a95a90a8a942025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2ozALCOHOLNingbo Rejoice Internationalb08fd11a-48e2-67b6-e053-2995a90ac3992025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Aloe 8ozALCOHOLNingbo Rejoice Internationalb1914c86-4489-fbb8-e053-2995a90a5cd62025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Coconut and Lime 3ozALCOHOLNingbo Rejoice Internationalbc07a905-b740-5e44-e053-2a95a90a4db92025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber and Melon 3ozALCOHOLNingbo Rejoice Internationalbc0810e9-2381-4212-e053-2995a90a264e2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Pomegranate and Vanilla 3ozALCOHOLNingbo Rejoice Internationalbc082139-f868-2f20-e053-2995a90ab9462025-02-13WarningsExact identifier
application number: M003
Rubbing Alcohol 91 percent isopropylISOPROPYL ALCOHOLWinCo Foods, LLC0ce2110d-ea9d-4d41-b0ae-6e9182f25abc2025-02-12WarningsExact identifier
application number: M003
XtraCare Wet WipesBENZETHONIUM CHLORIDERejoice International3741acc3-c590-4bf1-8c83-4f812e2c7adc2025-02-12WarningsExact identifier
application number: M003
Wet WipesBENZETHONIUM CHLORIDERejoice Internationalb4952aa6-a305-42df-b67e-82905be8a92d2025-02-12WarningsExact identifier
application number: M003
Wet WipesBENZETHONIUM CHLORIDERejoice International0ffcf0c2-409f-4dea-b296-b5ccb61399df2025-02-12WarningsExact identifier
application number: M003
Wet WipesBENZETHONIUM CHLORIDERejoice International5bdffa77-143d-4783-9aa4-971c084a94f52025-02-12WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse Fresh CitrusTRICLOSANRejoice International, Inc.e87ef6e6-ef41-43c4-bfdf-b7e3446436b72025-02-12WarningsExact identifier
application number: M003
XtraCare Cucumber MelonETHYL ALCOHOLRejoice International021fa2a0-d2ea-4699-a3d8-3c0af18c5aa32025-02-12WarningsExact identifier
application number: M003
XtraCare Lavender ChamomileETHYL ALCOHOLRejoice International6e611e87-1835-49f8-aa52-b724bd2515272025-02-12WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-012-036777700120324 BOTTLE, SPRAY in 1 CASE (67777-012-03) / 59.1 mL in 1 BOTTLE, SPRAY (67777-012-04) 2024-02-29NoNoCurrent
67777-012-046777700120459.1 mL in 1 BOTTLE, SPRAY59.1 mlHistorical