Dosage and administration
Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use
Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use
Store at 59° - 86°F (15°-30°C). Protect from freezing.
Benzocaine 200mg
Oral Anesthetic
For oral mucosa use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
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:
Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use
When using this product Avoid contact with eyes. If contact occurs, flush with water.
Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a physician before use.
Keep out of reach of children.
Store at 59° - 86°F (15°-30°C).
Protect from freezing.
flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.
crosstex@crosstex.com or
www.crosstex.com
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 238910 | benzocaine 20 % Oral Gel | PSN | 5 |
| 645497 | GumNumb 20 % Oral Gel | PSN | 5 |
| 645497 | benzocaine 0.2 MG/MG Oral Gel [Gum Numb Gel] | SBD | 5 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | 5 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | 5 |
| 645497 | Gum Numb Gel 0.2 MG/MG Oral Gel | SY | 5 |
| 645497 | Gumnumb 0.2 MG/MG Oral Gel | SY | 5 |
| 645497 | Gumnumb 20 % Oral Gel | SY | 5 |
| 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 |
|---|---|---|---|---|---|
| 24794-221-30 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-91e7-d83d-e063-dadaa90ab31f | 1b3e24cf-ecb6-4ddd-888a-333895eea66d |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24794-221-30 | Gumnumb Topical Anesthetic | 30 g in 1 JAR | GEL | 30 | 5 |
| 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 | INACTIVE INGREDIENT | SB8ZUX40TY | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 24794-221 | 24794-221-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| FD&C RED NO. 3 | PN2ZH5LOQY | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C GREEN NO. 3 | 3P3ONR6O1S | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| D&C GREEN NO. 5 | 8J6RDU8L9X | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION / INTRAVENOUS | 0.5 ml | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET / ORAL | 193 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | AEROSOL, POWDER / TOPICAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / ORAL | 665 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / TOPICAL | 11100 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, DELAYED RELEASE / ORAL | 10 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUPPOSITORY / RECTAL | 5704 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | OINTMENT / TOPICAL | 1179 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAVENOUS | 28216 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, CHEWABLE / ORAL | 84 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET / ORAL | 52 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUPPOSITORY / VAGINAL | 30 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION, CONCENTRATE / ORAL | 2813 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SPRAY, METERED / NASAL | 96 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, ORALLY DISINTEGRATING / ORAL | 0.16 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION / INTRAMUSCULAR | 56 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUSPENSION / SUBCUTANEOUS | 2.88 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, EXTENDED RELEASE / ORAL | 17 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SYRUP / ORAL | 740 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | CAPSULE, EXTENDED RELEASE / ORAL | 51 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / RECTAL | 290 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / VAGINAL | 1250 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, LIQUID FILLED / ORAL | 1122 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUPPOSITORY / RECTAL | 0.25 mg/mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 2 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CONCENTRATE / ORAL | 3000 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION/ DROPS / OPHTHALMIC | 1 %w/v | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION / INTRA-ARTICULAR | 56 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE / ORAL | 13440 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | CREAM / TOPICAL | 396 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / ORAL | 70200 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / INTRAMUSCULAR | 87 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUSPENSION, EXTENDED RELEASE / ORAL | 37 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | EMULSION / TOPICAL | 1.2 %w/w | ||
| 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 | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUSPENSION / ORAL | 900 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | WAFER / ORAL | 8 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / DENTAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / INTRASYNOVIAL | 87 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SPONGE / TOPICAL | NA | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / SOFT TISSUE | 87 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / INTRA-ARTICULAR | 56 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SOLUTION / ORAL | 199 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FILM COATED / ORAL | 2 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 |
|---|---|---|---|---|---|---|
| d618d90d-cd4f-4e4d-e053-2a95a90ad09b | 1b3e24cf-ecb6-4ddd-888a-333895eea66d | 2022-01-21 | Warnings | d618d90d-cd4f-4e4d-e053-2a95a90ad09b 1b3e24cf-ecb6-4ddd-888a-333895eea66d |