FDA.reportPublic FDA data

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 78 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl Alcohol WintergreenISOPROPYL ALCOHOLSafeway, Inc.14a22d1e-e498-4661-ab30-6696b8b914d72025-05-16WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLSafeway, Inc.69295fa8-0f0f-495c-a2ef-1414c6fa93a42025-05-16WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer - Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ebff92-c075-efdb-e063-6394a90a768f2025-05-12WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer - CaramelALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ec6817-98e4-2d8c-e063-6394a90ad5df2025-05-12WarningsExact identifier
application number: M003
Meijer Hydrating Power Mist Hand Sanitizer - GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ecbd68-ddab-3e47-e063-6294a90a2e502025-05-12WarningsExact identifier
application number: M003
Novo wipeALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.4ea50d30-b75b-44dc-bda1-d3ac97b34af72025-05-12WarningsExact identifier
application number: M003
Nozin Nasal Sanitizer (Antiseptic)ALCOHOLGlobal Life Technologies Corp.c670ac11-0656-4d85-868e-3a407c9952a32025-05-05WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a703b9-bcec-55ab-e063-6294a90af7822025-05-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a73f9f-faa2-89d5-e063-6294a90a4e0c2025-05-01WarningsExact identifier
application number: M003
The Pharma-C Company 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDEKleen Test Products Corporation7d1c94b1-66bd-4f22-beec-4975efd6b8162025-04-30WarningsExact identifier
application number: M003
POVIDONE-IODINE PREP PADS MEDIUMPOVIDONE-IODINE PREP PADS MEDIUMHF Acquisition Co. LLC, DBA HealthFirst33f08f03-93fb-214d-e063-6394a90a73bd2025-04-29WarningsExact identifier
application number: M003
SANSPRAYANTIBACTERIAL SANITIZER SPRAYBeacon Promotions Inc0e243179-37f6-45dc-e063-6394a90a5f802025-04-28WarningsExact identifier
application number: M003
Sanell Hand SanitizerALCOHOLOraLabs0a6cc2a8-f568-45ae-8d82-a70103c774c72025-04-28WarningsExact identifier
application number: M003
Sanell Hand SanitizerALCOHOLOraLabs7184b9ad-0125-413d-b054-f46239b8ca922025-04-28WarningsExact identifier
application number: M003
Pink Pineapple SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.73543eed-e022-4d51-b606-000dcc0232982025-04-28WarningsExact identifier
application number: M003
Vanilla Sugar SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.6c790c49-7b4a-4e07-b5ce-9a31db84e01f2025-04-28WarningsExact identifier
application number: M003
Strawberry Pound Cake SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.34750790-4eec-4a2d-9686-2c69c1db79e62025-04-28WarningsExact identifier
application number: M003
Sweet Coconut SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.f9062bbc-8534-4dcc-920a-19f13d1c0def2025-04-28WarningsExact identifier
application number: M003
Germ Attack 70% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375d44e-5af6-8c7f-e063-6394a90abb4b2025-04-25WarningsExact identifier
application number: M003
Germ Attack 91% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375e0d7-07fa-6489-e063-6294a90a91ec2025-04-25WarningsExact 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