Indications and uses
temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores
temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores
adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: ask a doctor
tamper evident packaging: Do not use if outer box or blister is open or damaged. store at room temperature protect contents from moisture
Drug Facts
| Active ingredients (in each lozenge) | Purpose |
|---|---|
| Benzocaine 15 mg | Oral pain reliever |
| Menthol 3.6 mg | Oral pain reliever |
temporary relief of occasional
Do not usein a child under 5 years of age.
Stop use and ask a doctor or dentist if
If pregnant or breast-feeding,ask a health professional before use.
Keep this and all drugs out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Do not exceed recommended dosage.
Glucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.
Call 1-800-616-2471
Dist. by:
Major Pharmaceuticals
Livonia, MI 48150 USA
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0309046255499 | GTIN-13: 0309046255499 EAN-13: 0309046255499 GTIN-12: 309046255499 UPC-A: 309046255499 GTIN storage (14 digits): 00309046255499 | 60002649 Major Cherry Benzocaine 18ct_Page_1.jpg |
| Data code | Data Matrix | 60002649 | 60002649 Major Cherry Benzocaine 18ct_Page_1.jpg |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0904-6255-49 | 2023-11-09 | C162847 | 48780-1 | d6a99b39-9f14-a426-e053-dadaa90af4c2 | Cēpacol ® SORE THROAT |
| 0904-6255-49 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9f14-a426-e053-dadaa90af4c2 | Cēpacol ® SORE THROAT |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-6255-49 | Sore Throat LogenzesSore Throat | 18 in 1 BLISTER PACK | LOZENGE | 18 | 5 | |
| 0904-6255-49 | Sore Throat LogenzesSore Throat | 18 in 1 CARTON | LOZENGE | 18 | 5 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6255-49 | EA - Each | 0904-6255 | a2eb59a3-971e-4b7e-9167-67437d055528 | 1 | 2013-07-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZOCAINE | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| BENZOCAINE | ACTIVE MOIETY | U3RSY48JW5 | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| ALLYL SUCROSE | INACTIVE INGREDIENT | VI3D59RW0U | 1 | |
| CORN SYRUP | INACTIVE INGREDIENT | 9G5L16BK6N | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| HYDROGENATED SOYBEAN OIL | INACTIVE INGREDIENT | A2M91M918C | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0904-6255 | 0904-6255-49 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| CORN SYRUP | 9G5L16BK6N | IACT |
| ALLYL SUCROSE | VI3D59RW0U | IACT |
| HYDROGENATED SOYBEAN OIL | A2M91M918C | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL | L7T10EIP3A | 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 |
|---|---|---|---|---|---|---|
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET / ORAL | 13.5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SUSPENSION / ORAL | 2500 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | ELIXIR / ORAL | 400 mg/1ml | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | TROCHE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET, EXTENDED RELEASE / ORAL | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SOLUTION / ORAL | 750 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET, EXTENDED RELEASE / ORAL | 96 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | ELIXIR / ORAL | 400 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SOLUTION / ORAL | 750 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | CAPSULE, EXTENDED RELEASE / ORAL | 28.5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | TABLET / ORAL | 14.07 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | CAPSULE, EXTENDED RELEASE / ORAL | 28.5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SUSPENSION / ORAL | 2500 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SUSPENSION, EXTENDED RELEASE / ORAL | 1500 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | TABLET, COATED / ORAL | 17 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 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 |
|---|---|---|---|---|---|---|
| Sore Throat Logenzes Sore Throat | BENZOCAINE AND MENTHOL | Major Pharmaceuticals | 11416620-4892-44ba-9780-db27efff6743 | 2026-02-24 | Warnings | 0904-6255-49 0904-6255 00904625549 4b972e11-08d1-5afd-e063-6294a90a97f1 11416620-4892-44ba-9780-db27efff6743 |
Adverse event summaries are temporarily unavailable. Other product information remains available.