FDA.reportPublic FDA data

Hand Wipes

Product NDC
77677-013
11-digit product format
776770013
Labeler code
77677
Product ID
77677-013_45390a64-fe31-4239-e063-6294a90ad920
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
SWAB
Route
TOPICAL
Labeler
Advanced Ultrasound Solutions Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-15
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
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
Hand Wipes
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c2abaa8-c152-470b-a4d9-5056815a1987Available 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
77677-013-01Hand Wipes1 in 1 PACKETSWAB17
77677-013-01Hand Wipes0.13 g in 1 PACKETSWAB0.137
77677-013-20Hand Wipes20 in 1 PACKAGESWAB207
77677-013-20Hand Wipes0.13 g in 1 PACKETSWAB0.137

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77677-013HAND WIPES (BENZALKONIUM CHLORIDE) SWAB [ADVANCED ULTRASOUND SOLUTIONS INC.]6Current NDC, Legacy NDC, 4 package rows20241211_2c2abaa8-c152-470b-a4d9-5056815a1987.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 43 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd12585502-c043-6ffb-e063-6394a90a66022026-01-08WarningsExact identifier
application number: M003
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d35899-8b70-14f0-e053-2995a90a5ce82026-01-08WarningsExact identifier
application number: M003
Germ AwayANTI-MICROBIAL WIPEUnico International Trading Corpa6b4eec4-0b12-3a00-e053-2a95a90a78352026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d0ce42-9076-143c-e053-2995a90aeeb62026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation261c7b8f-4adc-72ec-e063-6394a90a92112026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation144453a2-8335-77be-e063-6394a90ab6762026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d40204-3f69-7fb7-e053-2995a90a278b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIAL HAND WIPEUnico International Trading Corpad7d8546-d440-e661-e053-2a95a90a8fd32026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d47c07-12bd-3c8f-e053-2a95a90a95642026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d7f260-f5be-7940-e053-2995a90aaa032026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIALUnico International Trading Corpada02f20-07ef-9e90-e053-2995a90a0e8b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-BACTERIALUnico International Trading Corpadb59182-6541-2b35-e053-2a95a90a0f712026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
application number: M003
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
application number: M003
Gentian Violet 2%GENTIAN VIOLET 2%The Podiatree Company60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b82026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%Epic Medical Supply Corp.0da45476-46c3-428c-a2d9-70865d2b12772026-01-08WarningsExact identifier
application number: M003
Roll On Anti Perspirant Alcohol FreeALUMINUM CHLOROHYDRATEMedline Industries, LP4f706801-dc2d-48c4-aa06-92207d86e55e2026-01-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2c2abaa8-c152-470b-a4d9-5056815a19877
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2c2abaa8-c152-470b-a4d9-5056815a19877
1038558benzalkonium chloride 0.13 % Topical ClothSY2c2abaa8-c152-470b-a4d9-5056815a19877
1038558benzalkonium chloride 0.13 % Topical SwabSY2c2abaa8-c152-470b-a4d9-5056815a19877
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2c2abaa8-c152-470b-a4d9-5056815a19877
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2c2abaa8-c152-470b-a4d9-5056815a19877
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2c2abaa8-c152-470b-a4d9-5056815a19877

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77677-013-01776770013011 PACKET in 1 PACKET (77677-013-01) / .13 g in 1 PACKET1 packet2020-05-15NoNoCurrent
77677-013-207767700132020 PACKET in 1 PACKAGE (77677-013-20) / .13 g in 1 PACKET20 packet2020-05-150000-00-00NoNoCurrent