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 |
|---|---|---|---|---|---|---|
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | d22f7776-1b3c-4744-bcfe-8d9597218d73 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9c6a26e8-1253-49f7-9ce2-45c0d39f05c5 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 48178733-7433-41ec-b178-1314e0edab1a | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | af430cf4-f1b4-4b57-b8e3-87df96d655d3 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 2b089fec-cae3-4dc9-964d-d37f732a2f9f | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 6c137a93-4a34-4849-997f-bd0c572466ef | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | e8aa9709-e8f6-47a6-ab29-1fef2309786b | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 8c55b39c-8231-46a1-92ef-9fb4e3f40c1e | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9e82dc54-aeca-457f-b4b9-2f18cc269538 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 1a8f5964-770a-4d14-a7b6-18b5da9159b0 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 7209ceef-9842-400e-89fa-6f4f30053675 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 1bcb43d9-4e02-443a-8208-dd094f0203b0 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | fbac0cb4-0ccb-4d9d-9deb-a827c7bc8c66 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 891d54a9-5cbd-4897-90bf-ade9a3d046fc | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 59c03588-5421-4416-a25f-a4778b4d3ea3 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 68b643c0-a61e-4f68-9791-5f18f4fa8d81 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | e2e53f9c-5c5c-4771-8345-ff7dcc7bcc4e | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722cdf3-7671-eb27-e053-2a95a90a09c4 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722bf24-ae85-54f6-e053-2995a90a1d35 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721864d-0950-8379-e053-2a95a90a3bcb | 2025-01-16 | 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 |