Topicale
- Product NDC
- 10733-162
- 11-digit product format
- 107330162
- Labeler code
- 10733
- Product ID
- 10733-162_28dd1b61-76cb-9473-e063-6294a90a07eb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- OINTMENT
- 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
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 |
|---|---|
| 82824416-80de-76bd-e053-2a91aa0ad8b5 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10733-162-35 | Topicale | 35 g in 1 CARTON | OINTMENT | 35 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10733-162-35 | GM - Gram | 10733-162 | 8f45ba8d-d341-4577-a3f1-7c689ceb64a9 | 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 |
|---|---|---|---|---|---|---|
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | 584b38ce-d1ef-4ecc-a887-7c96e7f9669f | 2026-08-20 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Walgreens | fb93c7f6-e025-4cf2-9997-acfe9a0debdd | 2026-08-19 | Warnings | M022 |
| CVS Saline | NASAL | CVS PHARMACY | f02c41b0-c78e-41cd-aa4a-2756bbe92087 | 2026-08-19 | Warnings | M022 |
| Ludens Honey Licorice Throat Drops | MENTHOL | Prestige Brands Holdings, Inc. | 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac | 2026-08-19 | Warnings | M022 |
| Ludens Dual Relief | PECTIN AND MENTHOL | Prestige Brands Holdings, Inc. | d0213cb3-ec8e-40cc-82c9-694032f0490f | 2026-08-19 | Warnings | M022 |
| CVS Health Sore Throat Fast Relief Oral Anesthetic | PHENOL | CVS Pharmacy,Inc. | 4fb880db-2185-41ef-a5f9-8983a28d2c5b | 2026-08-17 | Warnings | M022 |
| CVS Sore Throat Cherry | PHENOL | CVS Pharmacy,Inc. | 887c68e0-ff44-4bad-b360-56fb99ed9c45 | 2026-08-17 | Warnings | M022 |
| CVS Sore Throat Menthol Flavor | PHENOL | CVS PHARMACY,INC. | 665be058-b965-4b78-80b0-dd8524180932 | 2026-08-17 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Harris Teeter, LLC | 7e5f175d-f0d6-4665-ac14-1873d6b99c80 | 2026-08-12 | Warnings | M022 |
| Gingicaine Gel Variety Pak | GINGICAINE GEL VARIETY PAK | Gingi-Pak a Division of the Belport | 62ed4ff3-18f6-5c67-e053-2991aa0a7792 | 2026-08-11 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent ReadyInCase | HYDROGEN PEROXIDE | P & L Development, LLC | b0866db5-3b0d-4478-9b3b-1f077d2f5393 | 2026-08-06 | Warnings | M022 |
| Ollie Fresh Mint | SODIUM FLUORIDE, POTASSIUM NITRATE | Brio Product Group LLC. | ebeec44f-3c22-43f2-9256-6ece6025c105 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 5868c5a1-273f-f023-e063-6394a90ac9d8 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58690bb5-9604-26a4-e063-6394a90afdbe | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586918cf-7b13-5999-e063-6294a90a88a9 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586924a0-322d-5dc3-e063-6294a90a1556 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58692e90-de74-52d3-e063-6394a90a9702 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586937ae-46af-7066-e063-6294a90ae53e | 2026-08-06 | Warnings | M022 |
| Freshness Blueberry Toothpaste100g | FRESHNESS BLUEBERRY TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d1dba-87fc-b676-e063-6294a90a1470 | 2026-08-06 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1042847 | benzocaine 18 % Topical Ointment | PSN | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 3 |
| 1049224 | Topicale 18 % Topical Ointment | PSN | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 3 |
| 1049224 | benzocaine 0.18 MG/MG Oral Ointment [Topicale] | SBD | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 3 |
| 1042847 | benzocaine 0.18 MG/MG Oral Ointment | SCD | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 3 |
| 1042847 | benzocaine 18 % Topical Ointment | SY | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 3 |
| 1049224 | Topicale 0.18 MG/MG Oral Ointment | SY | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 3 |
| 1049224 | Topicale 18 % Topical Ointment | SY | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10733-162-35 | 10733016235 | 35 g in 1 CARTON (10733-162-35) | 35 g | 2019-03-05 | No | No | Current |