Topicale
- Product NDC
- 10733-167
- 11-digit product format
- 107330167
- Labeler code
- 10733
- Product ID
- 10733-167_28dd17ff-9097-d336-e063-6394a90a00fd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- Medical Products Laboratories, Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-03-05
- Substance
- BENZOCAINE
- Active strength
- 180 mg/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topicale
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 180 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8281700c-10f9-841c-e053-2991aa0a918f | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10733-167-43 | Topicale | 43 g in 1 BOTTLE, PUMP | GEL | 43 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10733-167-43 | GM - Gram | 10733-167 | 7a8f812c-78dd-4d13-992d-402c63fed35e | 1 | 2022-06-06 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Lemon Glycerin | GLYCERIN | Dynarex Corporation | 99fc00ea-9d55-0380-e053-2995a90a2c0b | 2026-03-24 | Warnings | M022 |
| Vicks VapoCool Sore Throat | BENZOCAINE AND MENTHOL | The Procter & Gamble Manufacturing Company | 911a05de-cb3f-c1d2-e053-2995a90ae4be | 2026-03-23 | Warnings | M022 |
| Dual-FormulaToothpaste for sensitive teeth | DUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETH | Hangzhou Namei Zhikang Technology Co., Ltd. | 4d735f91-8abc-3a30-e063-6394a90a7639 | 2026-03-20 | Warnings | M022 |
| SmileCare Mouth Ulcer Gel | MENTHOL | Yantai Aien Biotechnology Co., Ltd. | 4d6db039-5b97-8f3f-e063-6294a90a9d85 | 2026-03-19 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f91e609-8ca5-0492-e053-2a95a90a85d0 | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f81ffa5-05fd-4eef-e053-2995a90aac3e | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f947366-9380-3fa9-e053-2a95a90ad49c | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f947672-4873-5546-e053-2a95a90a3c4b | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f9490c1-8bfe-3166-e053-2a95a90a7175 | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f94b65d-47e3-9c6b-e053-2a95a90aa1f8 | 2026-03-17 | Warnings | M022 |
| BencoCaine Topical Anesthetic | BENZOCAINE | Benco Dental | 4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b | 2026-03-17 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043c00a6-1346-7780-e063-6294a90a3d5a | 2026-03-12 | Warnings | M022 |
| ORAL PAIN RELIEF | BENZOCAINE | Nantong Health & Beyond Hygienic Products Inc. | a5f0be98-d47e-4307-8044-304a64db774b | 2026-03-11 | Warnings | M022 |
| SENSODYNE PRONAMEL Intensive Enamel Repair Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | a2f9d58b-671b-4427-a971-1fceff5f2323 | 2026-03-09 | Warnings | M022 |
| Sore Mouth Cleanser | HYDROGEN PEROXIDE | CVS Pharmacy, Inc. | a5dbaadf-76a8-4c48-af2d-f4455e9411f0 | 2026-03-09 | Warnings, Adverse reactions | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Sam's West, Inc | 78a3e024-73da-40b7-9d9c-099fd6ca9b9e | 2026-03-03 | Warnings | M022 |
| Sore Throat | PHENOL GLYCERIN | CVS PHARMACY, INC | 9683bcfb-2f7e-48a4-aa79-500ee8df099a | 2026-03-02 | Warnings | M022 |
| Spring Gene Oil Pulling Sensitivity | POTASSIUM NITRATE | Health and Natural Beauty USA Corp | 294051e3-69ec-4190-8b03-fa34988376b7 | 2026-02-26 | Warnings | M022 |
| Lolleez Watermelon | PECTIN | BFY LLC | 4ba8af8b-5a17-8b8c-e063-6394a90a63f3 | 2026-02-25 | Warnings | M022 |
| Oral Sore Antiseptic | HYDROGEN PEROXIDE, MENTHOL | H E B | f1450866-1be4-46d9-9fe4-52d699636b4f | 2026-02-24 | Warnings, Adverse reactions | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1042838 | benzocaine 18 % Oral Gel | PSN | 8281700c-10f9-841c-e053-2991aa0a918f | 3 |
| 1049213 | Topicale 18 % Oral Gel | PSN | 8281700c-10f9-841c-e053-2991aa0a918f | 3 |
| 1049213 | benzocaine 0.18 MG/MG Oral Gel [Topicale] | SBD | 8281700c-10f9-841c-e053-2991aa0a918f | 3 |
| 1042838 | benzocaine 0.18 MG/MG Oral Gel | SCD | 8281700c-10f9-841c-e053-2991aa0a918f | 3 |
| 1042838 | benzocaine 18 % Oral Gel | SY | 8281700c-10f9-841c-e053-2991aa0a918f | 3 |
| 1049213 | Topicale 0.18 MG/MG Oral Gel | SY | 8281700c-10f9-841c-e053-2991aa0a918f | 3 |
| 1049213 | Topicale 18 % Oral Gel | SY | 8281700c-10f9-841c-e053-2991aa0a918f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10733-167-43 | 10733016743 | 43 g in 1 BOTTLE, PUMP (10733-167-43) | 43 g | 2019-03-05 | No | No | Current |