FDA.reportPublic FDA data

Obstetrical Towelette

Product NDC
34645-0015
11-digit product format
346450015
Labeler code
34645
Product ID
34645-0015_085ce1b9-2645-8067-e063-6294a90afc04
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-01
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/g
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
Obstetrical Towelette
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/g

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
8db4eb14-85b6-4c8e-9623-39a43b3827a1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-0015-1Obstetrical Towelette1 in 1 POUCHCLOTH12
34645-0015-1Obstetrical Towelette1.6 g in 1 PATCHCLOTH1.62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0015OBSTETRICAL TOWELETTE (BENZALKONIUM CHLORIDE) CLOTH [JIANERKANG MEDICAL CO., LTD]2Current NDC, Legacy NDC, 2 package rows20231023_8db4eb14-85b6-4c8e-9623-39a43b3827a1.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 79 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear DefenseHAND SANITIZING WIPESMelaleuca, Inc.30dec472-8112-37d6-e063-6294a90a1f252025-04-24WarningsExact identifier
application number: M003
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.3347184c-ae72-bec2-e063-6294a90a2d052025-04-23WarningsExact identifier
application number: M003
Dukal Sterile Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC00b2c444-8601-4d8f-b6bb-91b864fd90412025-04-23WarningsExact identifier
application number: M003
PREVENT HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCee2c3dd2-a82f-4bbf-a288-f0365b9893db2025-04-23WarningsExact identifier
application number: M003
SANIFOAM HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCe1cfa8ff-92e0-4931-98c9-287c8dcd5a992025-04-23WarningsExact identifier
application number: M003
ANTIBACTERIAL WASH FOAM ITEM 1081CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC18720bd0-6ea8-2d1b-e063-6394a90abe2d2025-04-23WarningsExact identifier
application number: M003
E-2 HAND ITEM 1095CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC18728ebb-c416-5efe-e063-6294a90abd912025-04-23WarningsExact identifier
application number: M003
PEARL ANTIMICROBIAL HAND ITEM 1027AB-01CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871b1db-f881-e7fd-e063-6294a90ada982025-04-23WarningsExact identifier
application number: M003
SOFT TOUCH PLUS ANTIBACTERIAL HAND ITEM 1039CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1870b08e-e5c3-7888-e063-6394a90a1c822025-04-23WarningsExact identifier
application number: M003
SUPER SUDS ANTIBACTERIAL HAND ITEM 1063CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871e729-6b76-084e-e063-6394a90a795d2025-04-23WarningsExact identifier
application number: M003
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2c38a4be-fcbe-9d1d-e063-6294a90a93732025-04-22WarningsExact identifier
application number: M003
Sierra Soft Antibacterial WashCHLOROXYLENOLCWGC LA Inc.49034ae5-be47-4472-a4e5-b5bf633355ed2025-04-21WarningsExact identifier
application number: M003
AplicareHYDROGEN PEROXIDEAplicare Products LLC0b3e5df6-03c8-3880-e063-6394a90a1cdc2025-04-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDETotal Resources Internationalb971cc41-fe23-4be3-9564-e46d55df1d682025-04-18WarningsExact identifier
application number: M003
Sierra Soft Alcohol Hand SanitizerETHYL ALCOHOLCWGC LA Inc.012463da-94cf-4975-9fa2-6c323855bf572025-04-17WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp323c61fd-adee-393c-e063-6394a90a5eb32025-04-15WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp324b140d-9d43-1c2f-e063-6294a90ae3032025-04-15WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTARGET Corporation126ec829-c54c-4927-bbd5-a8156d2f6eea2025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b88e9f-d3e7-c78c-e063-6294a90a67072025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.3269a702-59a3-af3b-e063-6394a90a97d22025-04-14WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN8db4eb14-85b6-4c8e-9623-39a43b3827a12
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD8db4eb14-85b6-4c8e-9623-39a43b3827a12
1038558benzalkonium chloride 0.13 % Topical ClothSY8db4eb14-85b6-4c8e-9623-39a43b3827a12
1038558benzalkonium chloride 0.13 % Topical SwabSY8db4eb14-85b6-4c8e-9623-39a43b3827a12
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY8db4eb14-85b6-4c8e-9623-39a43b3827a12
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY8db4eb14-85b6-4c8e-9623-39a43b3827a12
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY8db4eb14-85b6-4c8e-9623-39a43b3827a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-0015-1346450015011 PATCH in 1 POUCH (34645-0015-1) / 1.6 g in 1 PATCH1 patch2021-08-010000-00-00NoNoCurrent