Home NDC 85454-0421 Onral Oral Pain Reliever Mouthwash
Product NDC 85454-0421
11-digit product format 854540421
Labeler code 85454
Product ID 85454-0421_36b1704e-640d-bab5-e063-6394a90a4145
Type HUMAN OTC DRUG
Nonproprietary name BENZOCAINE
Dosage form LIQUID
Route ORAL
Labeler Syka Pharma Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-01
Substance BENZOCAINE
Active strength 50 mg/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Onral Oral Pain Reliever Mouthwash
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2717653 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 85454-0421-1 Onral Oral Pain Reliever Mouthwash 1 in 1 CARTON LIQUID 1 1 85454-0421-1 Onral Oral Pain Reliever Mouthwash 230 mL in 1 BOTTLE, PLASTIC LIQUID 230 1
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 9 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85454-0421-1 85454042101 1 BOTTLE, PLASTIC in 1 CARTON (85454-0421-1) / 230 mL in 1 BOTTLE, PLASTIC 2025-07-01 No No Current