Oral Gel
- Product NDC
- 83650-101
- 11-digit product format
- 836500101
- Labeler code
- 83650
- Product ID
- 83650-101_299dca27-d254-e6ea-e063-6394a90a4f74
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine Benzalkonium Chloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Savvy Care and Cosmetics
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-22
- Substance
- BENZOCAINE; BENZALKONIUM CHLORIDE
- Active strength
- 20; .1 g/100g; g/100g
- 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
- Oral Gel
- Brand name suffix
- Oral Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 20 g/100g |
| BENZALKONIUM CHLORIDE | .1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| F5UM2KM3W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1595155 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 05ede7e4-5a0a-c942-e063-6294a90a8a24 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83650-101-01 | Oral GelOral Pain Relief | 42.5 g in 1 TUBE | GEL | 42.5 | 2 |
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 |
|---|---|---|---|---|---|---|
| Oral Gel Oral Pain Relief | BENZOCAINE BENZALKONIUM CHLORIDE | Savvy Care and Cosmetics | 05ede7e4-5a0a-c942-e063-6294a90a8a24 | 2024-12-19 | Warnings | M022 83650-101 |
| EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint | SODIUM BICARBONATE | Lotus Brands, Inc. | 4a95c8c1-db7c-4791-ac58-3eac216a0126 | 2024-12-18 | Warnings | M022 |
| EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon | SODIUM BICARBONATE | Lotus Brands, Inc. | 6703b29d-cdc9-4c74-91c0-fb0c98dd043e | 2024-12-18 | Warnings | M022 |
| Red Cross Oral Pain Relief | BENZOCAINE | The Mentholatum Company | cbd41429-f730-4577-9f06-ef1831cf62e1 | 2024-12-17 | Warnings | M022 |
| Red Cross Canker Sore | BENZOCAINE | The Mentholatum Company | 54cfff96-6665-4b36-a15d-10bf6cf3a1f9 | 2024-12-17 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | 116956644 | 2981217f-f250-c090-e063-6294a90a85b0 | 2024-12-17 | Warnings | M022 |
| Kank-A Mouth Pain | BENZOCAINE | Blistex Inc. | eebc03ba-f849-4e70-a653-834f383b6aa4 | 2024-12-17 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8282a4a6-b77c-75fc-e053-2991aa0ad4ac | 2024-12-16 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | 9452bff4-8c08-eff9-e053-2a95a90a67ed | 2024-12-16 | Warnings | M022 |
| PHENOL | PHENOL | CHAIN DRUG MARKETING ASSOCIATION INC. | 2379e23a-72fe-4e94-9d7e-9b623c0db174 | 2024-12-13 | Warnings | M022 |
| KANKA SoftBrush | BENZOCAINE AND ZINC CHLORIDE | Blistex Inc | 093f3545-1d8e-48a3-a533-e9c3ae6d740b | 2024-12-12 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 826eaef8-4457-3dc2-e053-2991aa0a528b | 2024-12-11 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8281700c-10f9-841c-e053-2991aa0a918f | 2024-12-11 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 2024-12-11 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | e3da0e63-a891-72bd-e053-2a95a90a58bc | 2024-12-11 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories, Inc. | e3d924b5-0788-46d3-e053-2995a90a027b | 2024-12-11 | Warnings | M022 |
| Fluoride Bits | SODIUM MONOFLUOROPHOSPHATE 0.76% | The Kind Lab, Inc. | fa433031-7376-0e5b-e053-6394a90a5f75 | 2024-12-11 | Warnings | M022 |
| Fluoride Bits | SODIUM MONOFLUOROPHOSPHATE 0.76% | The Kind Lab, Inc. | eedf13dc-a009-027a-e053-2995a90a8ec8 | 2024-12-11 | Warnings | M022 |
| NATURAL LEMON MINT HERB THROAT DROPS | MENTHOL | Ricola USA Inc. | 763e8234-60be-4b1f-9f78-01c574f35d0a | 2024-12-10 | Warnings | M022 |
| Natural Cherry Honey Herb Throat Drops | MENTHOL | Ricola USA Inc. | 989f8509-cd28-48e7-9aa1-baddfbcac95a | 2024-12-10 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1595155 | benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel | PSN | 05ede7e4-5a0a-c942-e063-6294a90a8a24 | 2 |
| 1595155 | benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel | SCD | 05ede7e4-5a0a-c942-e063-6294a90a8a24 | 2 |
| 1595155 | benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel | SY | 05ede7e4-5a0a-c942-e063-6294a90a8a24 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83650-101-01 | 83650010101 | 42.5 g in 1 TUBE (83650-101-01) | 42.5 g | 2023-09-22 | No | No | Current |