Home NDC 84128-013 Sponge with 4% w/w chlorhexidine gluconate (CHG)
Product NDC 84128-013
11-digit product format 841280013
Labeler code 84128
Product ID 84128-013_53f4c42d-9a3c-2f33-e063-6294a90a98d4
Type HUMAN OTC DRUG
Nonproprietary name Chlorhexidine Gluconate
Dosage form SPONGE
Route TOPICAL
Labeler Xinxiang Xinda Technology Co.,Ltd
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-27
Substance CHLORHEXIDINE GLUCONATE
Active strength 40 mg/mL
Pharmacologic classes Decreased Cell Wall Integrity [PE]
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 Sponge with 4% w/w chlorhexidine gluconate (CHG)
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORHEXIDINE GLUCONATE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MOR84MUD8E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2677515 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84128-013-01 84128001301 40 BAG in 1 BOX (84128-013-01) / 1 APPLICATOR in 1 BAG / 20 mL in 1 APPLICATOR 40 bag 2024-02-27 No No Current