Prodigium

Manufacturer
Price & Novelties, Inc | LEX, Inc
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:18:42

Label at a glance#

ProductProdigium
Active ingredientBENZOCAINE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: (%) Purpose

Benzocaine USP 10%..................Oral Anesthetic

OTC - PURPOSE SECTION

Purpose

Oral Anesthetic

INDICATIONS & USAGE SECTION

Uses

For temporary relief of pain associated with the following mouth and gum irritations:

  • toothache
  • sore gums
  • cranker sores
  • braces
  • minor dental procedures

WARNINGS SECTION

Warnings

Do not exceed recommended dosage

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the 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)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy alert

  • do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

OTC - DO NOT USE SECTION

Do not use:

  • for more than 7 days unless directed by a dentist or doctor.
  • For teething
  • in children under 2 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. If pregnant or breastfeeding, ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions


•adults and children over 12 years of age apply to the affected area. Gargle, swish around the mouth or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor. •children under 12 years of age should be supervised in the use of the product • Children under 2 years of age: Consult a dentist or doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients:


polyethylene glycol

OTC - QUESTIONS SECTION

Questions or comments?

787-781-3352

OTC - STOP USE SECTION

Stop use and consult a doctor promptly if:

  • symptoms do not improve in 7 days
  • swelling, rash, or fever develop
  • irritation, pain, or redness persist or worsen
  • symptoms persist for more than 7 days
  • allergic reaction occurs

Prodigium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54361-7020-1Prodigium4 mL in 1 VIAL, SINGLE-USELIQUID42

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54361-702054361-7020-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b3875b5-3b67-b786-e063-6394a90ae2181e8e0653-2f77-b62d-e063-6294a90a6c122025-01-08WarningsExact identifier
spl id: 2b3875b5-3b67-b786-e063-6394a90ae218
spl set id: 1e8e0653-2f77-b62d-e063-6294a90a6c12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.