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 84 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcohol 50 percent Wintergreen ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCf9ff67b0-c4ad-4162-b3ef-27a85ed0da252025-02-18WarningsExact identifier
application number: M003
Inverness Home Ear Piercing KitBENZALKONIUM CHLORIDEThe Richline Group, Inc.80909a34-21da-4c54-bb62-fd986fd24b042025-02-17WarningsExact identifier
application number: M003
Inverness EAR CARE ANTISEPTICBENZALKONIUM CHLORIDEThe Richline Groupac42d2f1-69e3-45f6-8002-d45ebed5ee222025-02-17WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Barbie 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e1507f1-a88f-4ef8-e063-6294a90a92fd2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Hot Wheels 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e159f8f-352c-45ca-e063-6394a90adf9b2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Crayola 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e1633f1-4b59-6eea-e063-6294a90ae61b2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Spider man 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e16c9bc-223d-0c65-e063-6294a90a48152025-02-14WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.3007da5f-e2ea-4f3a-905c-770782da014e2025-02-14WarningsExact identifier
application number: M003
50 percent Isopropyl alcoholISOPROPYL ALCOHOLWhole Foods Market6cb4ccca-96e7-43cb-ae05-95a411e712552025-02-14WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Lemon IceETHYL ALCOHOLNingbo Rejoice Internationala266624f-2175-2fd4-e053-2995a90a33052025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Watermelon Scented 1.8 oz.ETHYL ALCOHOLNingbo Rejoice Internationala2677a83-8f9a-7470-e053-2a95a90aa2892025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin E and Aloe Vera 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala2695f96-ef8c-bba6-e053-2a95a90a243e2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Original 1.8 ozETHYL ALCOHOLNingbo Rejoice Internationala26a866a-bb5f-4b5f-e053-2995a90a97452025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin E 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala269e72d-c74b-71ed-e053-2995a90ac1472025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala269a222-95cb-098c-e053-2995a90a21e72025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala346ebd2-fc31-b574-e053-2995a90a0d3a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala7364361-f8ad-fc71-e053-2995a90a68a12025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala73698ca-2097-3f7d-e053-2a95a90a638a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Lemon 2ozALCOHOLNingbo Rejoice Internationalb08ea7ef-a595-6bef-e053-2a95a90a68fb2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Original 8ozALCOHOLNingbo Rejoice Internationalb08ec92b-e63e-2dab-e053-2995a90a09482025-02-13WarningsExact 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