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#
Contacts and useful links#
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
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54361-7020-1 | Prodigium | 4 mL in 1 VIAL, SINGLE-USE | LIQUID | 4 | 2 |
Products#
Every source-derived product name is available through these pages.
- Prodigium
- Benzocaine 10%
- PROPYLENE GLYCOL
- BENZOCAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54361-7020 | 54361-7020-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2b3875b5-3b67-b786-e063-6394a90ae218 | 1e8e0653-2f77-b62d-e063-6294a90a6c12 | 2025-01-08 | Warnings | 2b3875b5-3b67-b786-e063-6394a90ae218 1e8e0653-2f77-b62d-e063-6294a90a6c12 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
