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 112 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdfe5eb694-4b1b-4c47-95d5-6074155c438a2023-11-09WarningsExact identifier
application number: M003
Leader Alcohol 70 Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health4b5d50cb-a8b4-4997-a8dd-26506c4cdc6d2023-11-09WarningsExact identifier
application number: M003
BZK Cleansing Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52c74f75-d7ef-481b-b580-fba402d03d752023-11-09WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd48d198f0-d505-4e45-b7c9-dd70658fd5fa2023-11-09WarningsExact identifier
application number: M003
Maokang 3 Hydrogen PeroxideHYDROGEN PEROXIDEChangzhou Maokang Medical Products Co., Ltdb4b478b9-426d-4864-a64c-31de9bbf5dc32023-11-09WarningsExact identifier
application number: M003
MK Sting Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1a60dd1b-0116-42a2-a501-4f74e326a2e92023-11-09WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn Care KitHEXYLRESORCINOLAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions5ddb84e9-cdf7-4034-acd2-625f8d6e46012023-11-08WarningsExact identifier
application number: M003
Inverness Ear PiercingBENZALKONIUM CHLORIDEThe Richline Group, Inc.bcec8099-939b-4cff-b388-f4046164f2d42023-11-08WarningsExact identifier
application number: M003
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
application number: M003
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.b4145aa4-d810-4c20-8493-311a7e222eb92023-11-05WarningsExact identifier
application number: M003
HYDROGEN PEROXIDEHYDROGEN PEROXIDEDEGASA SA DE CV26bae595-6e76-4946-b98f-1aba2e69250d2023-11-05WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
application number: M003
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
application number: M003
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
application number: M003
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0af-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08bf-5092-e054-00144ff8d46c2023-10-23WarningsExact 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