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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentists or doctor promptly. Do not exceed recommended dosage. Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, or other "caine" anesthetics. Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) rapid heart rate dizziness or lightheadedness headache shortness of breath atigue or lack of energy Keep out of reach of children

Additional Listing Data#

Finished product
Yes
Brand name base
Onral Oral Pain Reliever Mouthwash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui2717653

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85454-0421-1Onral Oral Pain Reliever Mouthwash1 in 1 CARTONLIQUID11
85454-0421-1Onral Oral Pain Reliever Mouthwash230 mL in 1 BOTTLE, PLASTICLIQUID2301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717653benzocaine 5 % MouthwashPSN5dd8d933-6f32-4eaf-8eca-9365d7de55a21
2717653benzocaine 50 MG/ML MouthwashSCD5dd8d933-6f32-4eaf-8eca-9365d7de55a21
2717653benzocaine 5 % MouthwashSY5dd8d933-6f32-4eaf-8eca-9365d7de55a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85454-0421-1854540421011 BOTTLE, PLASTIC in 1 CARTON (85454-0421-1) / 230 mL in 1 BOTTLE, PLASTIC2025-07-01NoNoCurrent