SPL UNCLASSIFIED SECTION
DRUG FACTS
DRUG FACTS
| Active Ingredients (in each 30 mL) | Purpose |
|---|---|
| Menthol 0.15% | Anesthetic/Analgesic |
| Zinc Chloride 0.1% | Astringent |
For the temporary relief of occasional minor throat irritation, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to minor dental procedures, pain due to minor irritations caused by dentures or orthodontic appliance, sore gums due to teething in infants and children 4 months of age and older.
Spray G-Bucal-C several times as directed by physician or dentist to affected are in the mouth or lips. Children under 12 years of age should be supervised in the use of this product. Children under two years of age consult a doctor or dentist. As a gargle or mouthwash, ½ teaspoon in a half glass of warm water. 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.
Benzocaine, cetylpyridinium chloride, citric acid, glycerin, peppermint oil, polyethylene glycol, purified water, sodium citrate and sodium saccharin.
Each 30mL Contains:
| Cetylpyridinium Chloride | 30 mg |
| Benzocaine | 600 mg |
| Menthol | 45 mg |
| Zinc Chloride | 30 mg |
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Do not use this product for more than 7 days unless directed by a dentist or doctor. If irritation, pain or redness persists or worsens, or if swelling, rash or fever develops, see your dentist or doctor promptly. DO NOT EXCEED RECOMMENDED DOSAGE. Do not use this product if you have history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Discontinue use and consult a doctor if irritation persists or increases or a rash appears on the skin. Fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your doctor. DO NOT USE IN OR NEAR THE EYES. In the event of accidental contact with eyes, flush immediately and continuously for ten minutes. See immediate medical attention if pain or irritation persists.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1291083 | benzocaine 2 % / cetylpyridinium Cl 0.1 % / menthol 0.15 % / zinc chloride 0.1 % Mucosal Spray | PSN | 1 |
| 1291083 | benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 1.5 MG/ML / zinc chloride 1 MG/ML Mucosal Spray | SCD | 1 |
| 1291083 | benzocaine 2 % / cetylpyridinium Cl 0.1 % / menthol 1.5 % / zinc chloride 0.1 % Mucosal Spray | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43913-402-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-793f-f424-e053-dadaa90a57ce | G-BUCAL-C |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43913-402-30 | G-BUCAL-C | 30 mL in 1 BOTTLE, SPRAY | SPRAY | 30 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43913-402-30 | ML - Milliliter | 43913-402 | df3d8a71-faa8-4db2-ba22-9175b234e1fb | 1 | 2016-11-08 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MENTHOL, UNSPECIFIED FORM | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| ZINC CHLORIDE | ACTIVE INGREDIENT | 86Q357L16B | 1 | |
| MENTHOL, UNSPECIFIED FORM | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 1 | |
| BENZOCAINE | INACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| CETYLPYRIDINIUM CHLORIDE | INACTIVE INGREDIENT | D9OM4SK49P | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 43913-402 | 43913-402-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
| ZINC CHLORIDE | 86Q357L16B | ACTIM |
| BENZOCAINE | U3RSY48JW5 | IACT |
| CETYLPYRIDINIUM CHLORIDE | D9OM4SK49P | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| POLYETHYLENE GLYCOLS | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | 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 |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRABURSAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / TOPICAL | 17 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAMUSCULAR | 26 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO / TOPICAL | 17 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / RESPIRATORY (INHALATION) | 0.13 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRACARDIAC | 1.05 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EFFERVESCENT / ORAL | 460 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / RESPIRATORY (INHALATION) | 8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / PERIDURAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / ORAL | 269 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION, CONCENTRATE / INTRAVENOUS | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, FILM COATED / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET / SUBLINGUAL | 0.15 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / ORAL | 665 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAOCULAR | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAVENOUS | 10 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 38 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SPRAY, METERED / SUBLINGUAL | 1 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CAPSULE / ORAL | 24 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET / ORAL | 28 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GRANULE, FOR SUSPENSION / ORAL | 113 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w |
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 |
|---|---|---|---|---|---|---|
| 8cf80886-2241-4e7c-af0e-50da491bf38e | 31690548-0a55-4d72-8733-591ba3a9be92 | 2015-06-29 | Warnings | 8cf80886-2241-4e7c-af0e-50da491bf38e 31690548-0a55-4d72-8733-591ba3a9be92 |
Adverse event summaries are temporarily unavailable. Other product information remains available.