FDA.reportPublic FDA data

First Aid Direct Antiseptic Wipe

Product NDC
42961-127
11-digit product format
429610127
Labeler code
42961
Product ID
42961-127_d4120dd5-cf03-466f-b7fa-da23c47b1999
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SPONGE
Route
TOPICAL
Labeler
Cintas Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-28
Substance
BENZALKONIUM CHLORIDE
Active strength
.133 mg/100mL
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
First Aid Direct Antiseptic Wipe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.133 mg/100mL

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
a23f3685-7213-4cc0-97b2-588fb1224792Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42961-127-01First Aid Direct Antiseptic Wipe1.4 mL in 1 PACKETSPONGE1.45
42961-127-02First Aid Direct Antiseptic Wipe10 in 1 BAGSPONGE105
42961-127-03First Aid Direct Antiseptic Wipe100 in 1 BOXSPONGE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-127FIRST AID DIRECT ANTISEPTIC WIPE (BENZALKONIUM CHLORIDE) SPONGE [CINTAS CORPORATION]3Current NDC, 3 package rows20241226_a23f3685-7213-4cc0-97b2-588fb1224792.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 89 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
application number: M003
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
application number: M003
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
application number: M003
EVR Povidone lodine WipePOVIDONE LODINEChangzhou Maokang Medical Products Co., Ltd.2b57e301-74e0-e1db-e063-6294a90a6c182025-01-10WarningsExact identifier
application number: M003
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
application number: M003
Medzah Ditek Alcohol Prep PadsISOPROPYL ALCOHOLMedzah Industries4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac2025-01-10WarningsExact identifier
application number: M003
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact identifier
application number: M003
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
application number: M003
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
application number: M003
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
application number: M003
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
application number: M003
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
application number: M003
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
application number: M003
Signature Care Alcohol Prep PadISOPROPYL ALCOHOLBetter Living Brands LLCadc87331-1aa1-3457-e053-2a95a90a7eb12025-01-03WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42961-127-01429610127011.4 mL in 1 PACKET1.4 mlHistorical
42961-127-024296101270210 PACKET in 1 BAG (42961-127-02) / 1.4 mL in 1 PACKET (42961-127-01) 10 packet2023-09-28NoNoCurrent
42961-127-0342961012703100 PACKET in 1 BOX (42961-127-03) / 1.4 mL in 1 PACKET (42961-127-01) 100 packet2023-09-28NoNoCurrent