FDA.reportPublic FDA data

ANTISEPTIC WIPE

Product NDC
64709-108
Requested package NDC
64709-108-40
11-digit product format
647090108
Labeler code
64709
Product ID
64709-108_3f2b1561-4cba-0f7b-e063-6394a90a2e1d
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE WIPE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Diamond Wipes International
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-23
Substance
BENZALKONIUM CHLORIDE
Active strength
13 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANTISEPTIC WIPE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE13 g/100g

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
0a49c713-56da-af45-e063-6394a90a8fceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64709-108-40ANTISEPTIC WIPE0.13 g in 1 BAGCLOTH0.133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64709-108ANTISEPTIC WIPE (BENZALKONIUM CHLORIDE WIPE) CLOTH [DIAMOND WIPES INTERNATIONAL]2Current NDC, 1 package rows20240629_0a49c713-56da-af45-e063-6394a90a8fce.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTISEPTIC WIPEBENZALKONIUM CHLORIDE WIPEDiamond Wipes International0a49c713-56da-af45-e063-6394a90a8fce2026-07-01WarningsExact identifier
ndc (package): 64709-108-40
ndc (product): 64709-108
ndc11 (package): 64709010840

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64709-108-4064709010840.13 g in 1 BAG (64709-108-40) 2023-11-23NoNoCurrent