Home NDC 34645-0015 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 Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038558 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 34645-0015-1 Obstetrical Towelette 1 in 1 POUCH CLOTH 1 2 34645-0015-1 Obstetrical Towelette 1.6 g in 1 PATCH CLOTH 1.6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 34645-0015 OBSTETRICAL TOWELETTE (BENZALKONIUM CHLORIDE) CLOTH [JIANERKANG MEDICAL CO., LTD] 2 Current NDC, Legacy NDC, 2 package rows 20231023_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 99 of 114 · 2,270 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 34645-0015-1 34645001501 1 PATCH in 1 POUCH (34645-0015-1) / 1.6 g in 1 PATCH 1 patch 2021-08-01 0000-00-00 No No Current