FDA.reportPublic FDA data

antiseptic towelette

Product NDC
82953-004
11-digit product format
829530004
Labeler code
82953
Product ID
82953-004_286c802e-e0fd-9b20-e063-6394a90a504a
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/1001
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
antiseptic towelette
Brand name suffix
01
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/1001

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
e9f2a1f1-ceb6-2f20-e053-2a95a90a18dbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-004-01antiseptic towelette0110 in 1 BAGCLOTH102
82953-004-02antiseptic towelette0115 in 1 BAGCLOTH152
82953-004-03antiseptic towelette0120 in 1 BAGCLOTH202
82953-004-04antiseptic towelette0130 in 1 BAGCLOTH302
82953-004-05antiseptic towelette0150 in 1 BAGCLOTH502
82953-004-06antiseptic towelette01100 in 1 BAGCLOTH1002
82953-004-07antiseptic towelette011 in 1 BAGCLOTH12
82953-004-08antiseptic towelette0110 in 1 JARCLOTH102
82953-004-09antiseptic towelette0120 in 1 JARCLOTH202
82953-004-10antiseptic towelette0130 in 1 JARCLOTH302
82953-004-11antiseptic towelette0150 in 1 JARCLOTH502
82953-004-12antiseptic towelette0160 in 1 JARCLOTH602
82953-004-13antiseptic towelette01100 in 1 JARCLOTH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-004ANTISEPTIC TOWELETTE 01 (BENZALKONIUM CHLORIDE) CLOTH [COSMUSES COSMETICS (NINGBO) CO., LTD.]2Current NDC, Legacy NDC, 13 package rows20241206_e9f2a1f1-ceb6-2f20-e053-2a95a90a18db.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 58 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health5459a0b4-65ca-455e-80b2-3fe1b24e01372025-10-23WarningsExact identifier
application number: M003
Hand Sanitizing WipesETHYL ALCOHOLPhoenix Healthcare Solutions LLCc68d2d73-be78-8e1c-e053-2995a90a3a372025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa7d77afc-588d-47d7-be2f-686ff3d75da22025-10-23WarningsExact identifier
application number: M003
Hand Sanitizing WipesETHYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCca9f8e68-cc15-42b4-81fd-e114e6a6d7df2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC50b24287-4c91-43d2-9c2e-42d3c086b3b32025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC51b707c6-df09-441b-a3d1-3f0c1b0886cc2025-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep SwabstickPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLC8a0aba34-3f96-46b6-8521-f4388fb73edf2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9c34be37-b6e2-4c08-96a5-d9bb0e738f2d2025-10-23WarningsExact identifier
application number: M003
Alcohol Swab SticksISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC91a9d6f7-d16c-46bf-8389-a6771e3ebfba2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9d79480c-ceef-49f7-a830-171c2a2629392025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health 200, Inc.a1bccbf5-9cee-46c0-890c-02eb3577c1932025-10-23WarningsExact identifier
application number: M003
Alcohol WipesISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC04c2ac54-1f44-a5d2-e063-6394a90a99cc2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC2a160c89-c438-455d-910d-ac359d46786f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe917b371-3ca9-94f0-e053-2a95a90af8ad2025-10-23WarningsExact identifier
application number: M003
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
application number: M003
CareTouch Alcohol Prep PadISOPROPYL ALCOHOLFuture Diagnostics Llc91cfd7bf-9f42-49d5-b20d-281779d5272d2025-10-23WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEPHOENIX HEALTHCARE SOLUTIONS, LLCdab5e937-bd92-467b-b1ac-a2428a814bc32025-10-23WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLWalmart Inc.067c3983-d450-e86b-e063-6294a90ab7582025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLFuture Diagnostics Llc45f6a1da-f0ab-4783-a211-7fba5dc0530e2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC24337cc6-98fe-ca0b-e063-6394a90a8b7b2025-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNe9f2a1f1-ceb6-2f20-e053-2a95a90a18db2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDe9f2a1f1-ceb6-2f20-e053-2a95a90a18db2
1038558benzalkonium chloride 0.13 % Topical ClothSYe9f2a1f1-ceb6-2f20-e053-2a95a90a18db2
1038558benzalkonium chloride 0.13 % Topical SwabSYe9f2a1f1-ceb6-2f20-e053-2a95a90a18db2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYe9f2a1f1-ceb6-2f20-e053-2a95a90a18db2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYe9f2a1f1-ceb6-2f20-e053-2a95a90a18db2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYe9f2a1f1-ceb6-2f20-e053-2a95a90a18db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82953-004-018295300040110 CLOTH in 1 BAG (82953-004-01) 10 cloth2022-10-130000-00-00NoNoCurrent
82953-004-028295300040215 CLOTH in 1 BAG (82953-004-02) 15 cloth2022-10-130000-00-00NoNoCurrent
82953-004-038295300040320 CLOTH in 1 BAG (82953-004-03) 20 cloth2022-10-130000-00-00NoNoCurrent
82953-004-048295300040430 CLOTH in 1 BAG (82953-004-04) 30 cloth2022-10-130000-00-00NoNoCurrent
82953-004-058295300040550 CLOTH in 1 BAG (82953-004-05) 50 cloth2022-10-130000-00-00NoNoCurrent
82953-004-0682953000406100 CLOTH in 1 BAG (82953-004-06) 100 cloth2022-10-130000-00-00NoNoCurrent
82953-004-07829530004071 CLOTH in 1 BAG (82953-004-07) 1 cloth2022-10-130000-00-00NoNoCurrent
82953-004-088295300040810 CLOTH in 1 JAR (82953-004-08) 10 cloth2022-10-130000-00-00NoNoCurrent
82953-004-098295300040920 CLOTH in 1 JAR (82953-004-09) 20 cloth2022-10-130000-00-00NoNoCurrent
82953-004-108295300041030 CLOTH in 1 JAR (82953-004-10) 30 cloth2022-10-130000-00-00NoNoCurrent
82953-004-118295300041150 CLOTH in 1 JAR (82953-004-11) 50 cloth2022-10-130000-00-00NoNoCurrent
82953-004-128295300041260 CLOTH in 1 JAR (82953-004-12) 60 cloth2022-10-130000-00-00NoNoCurrent
82953-004-1382953000413100 CLOTH in 1 JAR (82953-004-13) 100 cloth2022-10-130000-00-00NoNoCurrent