FDA.reportPublic FDA data

MED NAP Benzalkonium Chloride Antiseptic

Product NDC
0924-0246
11-digit product format
009240246
Labeler code
0924
Product ID
0924-0246_2682a042-f9ba-30dc-e063-6394a90a9e33
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Acme United Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-11
Substance
BENZALKONIUM CHLORIDE
Active strength
.0018 mg/1.35mL
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
MED NAP Benzalkonium Chloride Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.0018 mg/1.35mL

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
d7c404c1-c765-a67c-e053-2995a90a6b8eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-0246-00MED NAP Benzalkonium Chloride Antiseptic1.35 mL in 1 PACKETLIQUID1.353
0924-0246-01MED NAP Benzalkonium Chloride Antiseptic1.35 mL in 1 PACKETLIQUID1.353
0924-0246-01MED NAP Benzalkonium Chloride Antiseptic100 in 1 BOXLIQUID1003
0924-0246-02MED NAP Benzalkonium Chloride Antiseptic1.35 mL in 1 PACKETLIQUID1.353
0924-0246-02MED NAP Benzalkonium Chloride Antiseptic1000 in 1 BOXLIQUID10003
0924-0246-03MED NAP Benzalkonium Chloride Antiseptic1.35 mL in 1 PACKETLIQUID1.353
0924-0246-03MED NAP Benzalkonium Chloride Antiseptic12000 in 1 BOXLIQUID120003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-0246MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC (BENZALKONIUM CHLORIDE) LIQUID [ACME UNITED CORPORATION]3Current NDC, Legacy NDC, 7 package rows20241111_d7c404c1-c765-a67c-e053-2995a90a6b8e.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 115 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
application number: M003
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
application number: M003
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
application number: M003
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
application number: M003
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0924-0246-00009240246001.35 mL in 1 PACKET (0924-0246-00) 1.35 ml2022-02-110000-00-00NoNoCurrent
0924-0246-0100924024601100 PACKET in 1 BOX (0924-0246-01) / 1.35 mL in 1 PACKET100 packet2022-02-110000-00-00NoNoCurrent
0924-0246-02009240246021000 PACKET in 1 BOX (0924-0246-02) / 1.35 mL in 1 PACKET1000 packet2022-02-110000-00-00NoNoCurrent
0924-0246-030092402460312000 PACKET in 1 BOX (0924-0246-03) / 1.35 mL in 1 PACKET12000 packet2022-02-110000-00-00NoNoCurrent