FDA.reportPublic FDA data

New Skin Bandage

Product NDC
16864-440
11-digit product format
168640440
Labeler code
16864
Product ID
16864-440_4973ca2b-3a74-d8d0-e063-6394a90a9d0e
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Advantice Health, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-01
Substance
BENZETHONIUM CHLORIDE
Active strength
1.8 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
New Skin Bandage
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE1.8 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
60996119-8367-4e22-b6ec-c36490635fa4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-440-01New Skin Bandage1 in 1 BOXLIQUID18
16864-440-01New Skin Bandage30 mL in 1 BOTTLE, WITH APPLICATORLIQUID308
16864-440-02New Skin Bandage1 in 1 BOXLIQUID18
16864-440-02New Skin Bandage10 mL in 1 BOTTLE, WITH APPLICATORLIQUID108
16864-440-03New Skin Bandage1 in 1 BOXLIQUID18
16864-440-03New Skin Bandage13 mL in 1 BOTTLE, WITH APPLICATORLIQUID138
16864-440-04New Skin Bandage8 in 1 BOXLIQUID88
16864-440-04New Skin Bandage8 mL in 1 PACKETLIQUID88
16864-440-05New Skin Bandage16 in 1 BOXLIQUID168
16864-440-05New Skin Bandage8 mL in 1 PACKETLIQUID88

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16864-440-01ML - Milliliter16864-44031024832-9393-404f-87ce-3f1dfa328d0512018-12-13
16864-440-02ML - Milliliter16864-440f5c55d29-1709-41fd-9c61-fc202b59ea2812018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-440NEW SKIN BANDAGE (BENZETHONIUM CHLORIDE) LIQUID [ADVANTICE HEALTH, LLC]7Current NDC, Legacy NDC, 10 package rows20241215_60996119-8367-4e22-b6ec-c36490635fa4.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 41 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3afde78-b9f6-3648-e053-2a95a90a40242026-01-15WarningsExact identifier
application number: M003
BIOPURE Hand Sanitizer Spray-Coastal GlowHAND SANITIZER SPRAYQuest USA Corp48254577-9f1e-9389-e063-6394a90a92f12026-01-15WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487a4c8e-4fb3-6bff-e063-6294a90abd532026-01-15WarningsExact identifier
application number: M003
Gold Bond Hydrating Hand SanitizerETHYL ALCOHOLChattem, Inc.96fe0191-0d34-4bf3-8f93-0e64764c353a2026-01-14WarningsExact identifier
application number: M003
Alcohol Prep AwabsISOPROPYL ALCOHOLEnlightening Pallet Industry Co., Limited26c7db1e-86a9-8765-e063-6294a90a634f2026-01-14WarningsExact identifier
application number: M003
Caring HandsHAND MOISTURIZING SANITIZERGleeco Labs LLC2ced5dc5-47dd-1b71-e063-6394a90a0e3d2026-01-14WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLDealMed Medical Supplies LLC04e6edb5-07ef-4ed4-ba68-ed183386b5ab2026-01-13WarningsExact identifier
application number: M003
Dermoplast First AidBENZETHONIUM CHLORIDE AND BENZOCAINEAdvantice Health, LLCec93011d-7069-4021-8dd2-3d51eb6026e12026-01-13WarningsExact identifier
application number: M003
WISH ISOPROPYL ALCOHOLWISH ISOPROPYL ALCOHOLClick Products LLC484befce-ecfe-5514-e063-6294a90a169c2026-01-13WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 32ozWISH RUBBING ALCOHOL 32OZ 70%CLICK PRODUCTS LLC4836b564-0b8c-2fb4-e063-6394a90a9c4a2026-01-13WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEDealMed Medical Supplies LLC6d1ddf10-8873-4781-9165-bb1c4bbccfc92026-01-13WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e2c51699-d4da-5b88-e053-2995a90afd7f2026-01-12WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e297b705-8070-f7c3-e053-2a95a90a8c5b2026-01-12WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHydrox Laboratories6e5709b4-cc56-4768-b704-1d9b0e3efec72026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol 50%ISOPROPYL ALCOHOL 50%Hydrox Laboratories930bb3a3-5ca3-414c-b4fb-c71ee17fc7462026-01-12WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINESion Biotext Medical Ltd04438f9e-302c-431b-b3ad-d2c50ca01ad82026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratoriesf2f07464-6bd5-434c-8dea-0ba659c0e5492026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 70%ISOPROPYL ALCOHOL WITH WINTERGREEN 70%Hydrox Laboratories5845f723-8866-4738-bec6-621041899f572026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratories2042cf29-52c5-4f1e-aae6-78e025994d182026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 50%ISOPROPYL ALCOHOL WITH WINTERGREEN 50%Hydrox Laboratories3a15a900-2b48-487f-b252-a1a1e0d0abfc2026-01-12WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16864-440-01168640440011 BOTTLE, WITH APPLICATOR in 1 BOX (16864-440-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR2011-03-010000-00-00NoNoCurrent
16864-440-02168640440021 BOTTLE, WITH APPLICATOR in 1 BOX (16864-440-02) / 10 mL in 1 BOTTLE, WITH APPLICATOR2011-03-010000-00-00NoNoCurrent
16864-440-03168640440031 BOTTLE, WITH APPLICATOR in 1 BOX (16864-440-03) / 13 mL in 1 BOTTLE, WITH APPLICATOR2011-03-010000-00-00NoNoCurrent
16864-440-04168640440048 PACKET in 1 BOX (16864-440-04) / 8 mL in 1 PACKET8 packet2026-01-01NoNoCurrent
16864-440-051686404400516 PACKET in 1 BOX (16864-440-05) / 8 mL in 1 PACKET16 packet2026-01-01NoNoCurrent