Home NDC 87083-012 Toothache
Product NDC 87083-012
11-digit product format 870830012
Labeler code 87083
Product ID 87083-012_54ad2ceb-2730-e5ba-e063-6394a90aec5f
Type HUMAN OTC DRUG
Nonproprietary name Polyhexamethylene Biguanide Hydrochloride
Dosage form SPRAY
Route TOPICAL
Labeler Guchutang Biotechnology (Longyan) Co., Ltd
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-20
Substance POLIHEXANIDE HYDROCHLORIDE
Active strength .25 g/100mL
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 Toothache
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLIHEXANIDE HYDROCHLORIDE .25 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4XI6112496 Internal UNII 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 28 of 40 · 782 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87083-012-01 87083001201 30 mL in 1 BOTTLE (87083-012-01) 30 ml 2026-06-20 No No Current