Home NDC 77955-004 Antibacterial
Product NDC 77955-004
11-digit product format 779550004
Labeler code 77955
Product ID 77955-004_45896fff-efda-342e-e063-6394a90a7b39
Type HUMAN OTC DRUG
Nonproprietary name Chloroxylenol
Dosage form GEL
Route TOPICAL
Labeler Custom Chemical Solutions
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-19
Substance CHLOROXYLENOL
Active strength .01 mg/mL
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 Antibacterial
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOROXYLENOL .01 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0F32U78V2Q Internal UNII 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 77955-004-02 Antibacterial 1000 mL in 1 BOTTLE GEL 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77955-004 ANTIBACTERIAL (ALCOHOL) GEL [CUSTOM CHEMICAL SOLUTIONS] 3 Current NDC, Legacy NDC, 1 package rows 20240123_b9492b5a-9097-4f3c-e053-2a95a90a6650.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 77955-004-02 77955000402 1000 mL in 1 BOTTLE (77955-004-02) 1000 ml 2021-01-19 0000-00-00 No No Current