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 |
|---|---|---|---|---|---|---|
| Burkhart | STANNOUS FLUORIDE | Burkhart Dental Supply Inc | 048c9978-e32e-4f77-9a4e-40acd5fcdfaf | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | aa09dcc0-e641-4c6d-8a84-ba890c0fce4c | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | 4255da05-d264-4a4c-bd67-53d4862c0682 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | 2282ea74-94c1-40be-a77f-290763a76250 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | 99bce4c6-4593-40a1-b28d-8334a79b9d42 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | aa233c68-c6ac-44a5-b50e-3f5cd843bd25 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | bb11bfb4-1b50-48c6-8273-452b47b47833 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | 867cef7b-fe6e-4a45-87c1-35579a681c6c | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | c6238079-0bcc-4c35-9b73-455252d41ee5 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | b144aca9-91d1-4106-a39c-b928192ad41e | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | 0192ccf9-1715-4e23-a6bf-8bd838cd8b0d | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | edcb8451-6fa7-4bc2-95f6-2a0806f7f3da | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | 576660ed-203a-4842-9d39-c5be10daf976 | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | 1796b3ec-833a-4cf1-ba50-bc4da827f84f | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | d923fa75-f556-45e3-9f52-39a62e89984b | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | cd3ede8c-2c77-4d81-8dff-8198025a2156 | 2025-01-09 | Warnings | M022 |
| KAYLAAN | ZERO WASTE REFILL FOR TOOTHPASTE | Kaylaan LLC | cb7f5f9b-4192-15e6-e053-2995a90a6457 | 2025-01-09 | Warnings | M022 |
| KAYLAAN | ZERO WASTE REFILL FOR TOOTHPASTE | Kaylaan LLC | 2b494372-de59-e462-e063-6294a90a08da | 2025-01-09 | Warnings | M022 |
| Dental City Topical Anesthetic | BENZOCAINE | ICP Inc DBA Dental City | a225d515-430d-4e34-846c-0bfec3e74109 | 2025-01-09 | Warnings | M022 |
| Dental City Topical Anesthetic | BENZOCAINE | ICP Inc DBA Dental City | 372f99c9-4ad3-4631-b8c8-2a34c47343cc | 2025-01-09 | Warnings | 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 |