OTC - ACTIVE INGREDIENT SECTION
INGREDIENTS
Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and FD&C Red #40.
Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and FD&C Red #40.
For oral mucosal use only as directed by a dentist.
Federal law prohibits dispensing without a prescription.
Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.
Store at controlled room temperature 59-86°F (15-30°C).
MADE IN U.S.A.
Distributed by:
PATTERSON DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50227-2115-1 | 2019-11-13 | C162847 | 48780-1 | 97449f38-bf30-f6ea-e053-dbdaa90aa703 | Patterson Topical Anesthetic Cherry Flavor |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50227-2115-1 | Topical Anesthetic Cherry | 29.6 g in 1 JAR | GEL | 29.6 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50227-2115 | TOPICAL ANESTHETIC CHERRY (BENZOCAINE) GEL [PATTERSON DENTAL SUPPLY INC] | 1 | Legacy NDC, 1 package rows | 20120502_3e2b5f80-203a-41cf-bd7c-d118578a5fd3.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Benzocaine | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| Benzocaine | ACTIVE MOIETY | U3RSY48JW5 | 1 | |
| Polyethylene Glycol 3350 | INACTIVE INGREDIENT | G2M7P15E5P | 1 | |
| Polyethylene Glycol 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| Saccharin Sodium Dihydrate | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50227-2115 | 50227-2115-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzocaine | U3RSY48JW5 | ACTIB |
| Polyethylene Glycol 400 | B697894SGQ | IACT |
| Saccharin Sodium Dihydrate | SB8ZUX40TY | IACT |
| Polyethylene Glycol 3350 | G2M7P15E5P | IACT |
| Water | 059QF0KO0R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | WAFER / ORAL | 8 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUPPOSITORY / VAGINAL | NA | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, ORALLY DISINTEGRATING / ORAL | 0.16 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION / INTRAVENOUS | 0.5 ml | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / TOPICAL | 11100 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / ORAL | 665 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, CHEWABLE / ORAL | 15 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAVENOUS | 28216 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUPPOSITORY / VAGINAL | 30 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, FILM COATED / ORAL | 20 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, COATED / ORAL | 0.5 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / INTRAMUSCULAR | 87 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, EXTENDED RELEASE / ORAL | 17 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | CAPSULE, EXTENDED RELEASE / ORAL | 51 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION / INTRA-ARTICULAR | 56 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / TOPICAL | 6300 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FILM COATED / ORAL | 2 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | AEROSOL, POWDER / TOPICAL | NA | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / ORAL | 43 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUSPENSION, EXTENDED RELEASE / ORAL | 37 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUPPOSITORY / RECTAL | 5704 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / BUCCAL | 0.4 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / INTRASYNOVIAL | 87 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / RECTAL | 290 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, DELAYED RELEASE / ORAL | 10 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / VAGINAL | 1250 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, LIQUID FILLED / ORAL | 1122 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAMUSCULAR | 406 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | ELIXIR / ORAL | 15 mg/5ml | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / INTRALESIONAL | 87 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | FILM, SOLUBLE / ORAL | 29 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE / ORAL | 13440 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | CAPSULE / ORAL | 576 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SPONGE / TOPICAL | NA | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION / INTRASYNOVIAL | 3 %w/v | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / OPHTHALMIC | 46 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | CAPSULE / ORAL | 24 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | CREAM / TOPICAL | 396 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / ORAL | 70200 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | EMULSION / TOPICAL | 1.2 %w/w | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUSPENSION / ORAL | 900 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SWAB / TOPICAL | 5250 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg |
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 |
|---|---|---|---|---|---|---|
| 33c213ed-f380-4b4b-90cd-8ead44c7d8a5 | 3e2b5f80-203a-41cf-bd7c-d118578a5fd3 | 2012-04-06 | Warnings | 33c213ed-f380-4b4b-90cd-8ead44c7d8a5 3e2b5f80-203a-41cf-bd7c-d118578a5fd3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.