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 |
|---|---|---|---|---|---|---|
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043bfbc3-c33a-78b7-e063-6294a90a1a5a | 2024-10-29 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043a3cb4-f560-0ffd-e063-6394a90a2ff6 | 2024-10-29 | Warnings | M022 |
| Amosan Oral Wound Cleanser Mint | SODIUM PERBORATE MONOHYDRATE | Vintage Brands Limited | be57ca56-834f-4170-a407-f193484d8b0a | 2024-10-29 | Warnings | M022 |
| SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint | SODIUM FLUORIDE | Haleon US Holdings LLC | 817c0dad-d109-428e-adb5-3354604acc94 | 2024-10-28 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 1f3d68f6-afd6-42e7-b3e5-210228c8e7de | 2024-10-28 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals LLC | 0dd15227-6603-42ac-9a5f-f2dc49e0382a | 2024-10-28 | Warnings, Adverse reactions | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 0605d5d6-82bd-415e-b5cb-e273f934a4a7 | 2024-10-28 | Warnings | M022 |
| HurriCaine Topical Anesthetic Liquid | BENZOCAINE | Beutlich Pharmaceuticals, LLC | f70fa3fc-cd65-4a80-9efd-129e98fd3998 | 2024-10-28 | Warnings | M022 |
| Sore Throat Relief Menthol | PHENOL | Chain Drug Consortium | af661ef0-cdc3-4146-8ae5-59795aa49650 | 2024-10-28 | Warnings | M022 |
| Sore Throat Relief Cherry Flavor | PHENOL | Chain Drug Consortium | a9cf9829-4b70-44fa-9719-240b65c06724 | 2024-10-28 | Warnings | M022 |
| Ear Wax Removal Aid Drops | CARBAMIDE PEROXIDE | PHARMACY VALUE ALLIANCE, LLC | 85ae80c1-2bc2-4c90-9559-63510d03e739 | 2024-10-28 | Warnings | M022 |
| Chloraspetic | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | 2b1808b2-2574-4ab8-a762-5733251848ce | 2024-10-25 | Warnings | M022 |
| Chloraseptic Warming Sore Throat | PHENOL | Prestige Brands Holdings, Inc. | a197fab2-70ce-4a6c-9add-29d7368a75c5 | 2024-10-25 | Warnings | M022 |
| Gly-Oxide | CARBAMIDE PEROXIDE | Medtech Products Inc. | 086a0b82-e947-41c9-89e7-ba06483960c9 | 2024-10-25 | Warnings | M022 |
| CHLORASEPTIC | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | d500f423-b9f2-4d98-8f2a-8bab7c05737c | 2024-10-25 | Warnings | M022 |
| CHLORASEPTIC | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | b30e4b32-89dd-4e53-81d5-1415105361d4 | 2024-10-25 | Warnings | M022 |
| Finafta MultiOral | BENZOCAINE | Efficient Laboratories Inc. | 28c5a993-fb5f-4091-af15-32ccae4b9a7d | 2024-10-14 | Warnings | M022 |
| Rexall Sensitive Freshmint | POTASSIUM NITRATE, SODIUM FLUORIDE | Old East Main CO. | 7e715bb9-666e-4de4-ba70-1c84f5243443 | 2024-10-14 | Warnings | M022 |
| Rexall Sensitive Extra Whitening | POTASSIUM NITRATE, SODIUM FLUORIDE | Old East Main CO. | 2daf18a3-f71e-4585-8128-4663eff7eb6d | 2024-10-14 | Warnings | M022 |
| Anadent Kanka Gel | BENZOCAINE | BELMORA LLC | e0f73d78-5db1-43b4-8f58-e5410ca4560f | 2024-10-04 | 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 |