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 |
|---|---|---|---|---|---|---|
| GingiCaine Gel, Pina Colada | GINGICAINE GEL, PINA COLADA FLAVOR | Gingi-Pak a Division of the Belport | 6284e1fe-be33-69bf-e053-2991aa0a90ab | 2026-06-29 | Warnings | M022 |
| GingiCaine Gel, Chocolate Mint | GINGICAINE GEL, CHOCOLATE MINT FLAVOR | Gingi-Pak a Division of the Belport | 6285c4f2-c139-49a9-e053-2991aa0a2b03 | 2026-06-29 | Warnings | M022 |
| UltraCare Anesthetic Gel | BENZOCAINE | The Bellport Company, Inc. dba Gingi-Pak | f5dd8fa8-0b6a-5a30-e053-2995a90ad194 | 2026-06-26 | Warnings | M022 |
| GingiCaine Gel | GINGICAINE GEL BANANA FLAVOR | Gingi-Pak a Division of the Belport | 62857d06-a829-4efa-e053-2991aa0a6d15 | 2026-06-25 | Warnings | M022 |
| GingiCaine Gel, Cotton Candy Flavor | GINGICAINE GEL, COTTON CANDY FLAVOR | Gingi-Pak a Division of the Belport | 628515a5-175f-ac2c-e053-2991aa0a19ce | 2026-06-25 | Warnings | M022 |
| Perox-A-Mint Solution | HYDROGEN PEROXIDE | Sage Products, LLC | 50823ff5-ad08-4449-bc4a-9a8ae25ec0d5 | 2026-06-24 | Warnings | M022 |
| Antiseptic Oral Rinse | CETYLPYRIDINIUM CHLORIDE | Sage Products LLC | efff8bae-154d-46bc-8dd4-716800425663 | 2026-06-24 | M022 | |
| Anbesol Maximum Strength | BENZOCAINE | Foundation Consumer Brands | 8c6ac499-9bd2-4ea5-9f26-df7947bff4a6 | 2026-06-22 | Warnings | M022 |
| Anbesol Maximum Strength | BENZOCAINE | Foundation Consumer Brands | dcc37403-0192-4658-bb7a-059273ce0047 | 2026-06-22 | Warnings | M022 |
| Toothache | POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE | Guchutang Biotechnology (Longyan) Co., Ltd | 54ad2ceb-272f-e5ba-e063-6394a90aec5f | 2026-06-20 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Delon Laboratories (1990) Ltd | d4aa09bf-8207-47dd-bc42-01e660da9438 | 2026-06-16 | Warnings | M022 |
| TideFresh MOUTH SORE AND TOOTHACHE | BENZOCAINE 20% MOUTH SORE AND TOOTHACHE | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 541e1814-c00e-efdf-e063-6394a90a41a1 | 2026-06-13 | Warnings | M022 |
| Chloraseptic Sore Throat Max | PHENOL AND GLYCERIN | Prestige Brands Holdings, Inc. | 882c940c-b3c3-4aa4-8d64-e4260f066ff4 | 2026-06-08 | Warnings | M022 |
| Orazen | SODIUM MONOFLUOROPHOSPHATE | Orazen Inc | fa5b6bd8-443f-79e7-e053-6394a90a5513 | 2026-06-03 | Warnings | M022 |
| Fishermans Friend Mixed Berry | MENTHOL | Lofthouse of Fleetwood | 53391c4d-ee2d-ade3-e063-6394a90ac77d | 2026-06-01 | Warnings | M022 |
| Orajel Medicated for Toothache and Gum, Liquid | BENZOCAINE AND MENTHOL | Church & Dwight Co., Inc. | ac3d605d-241d-1a6f-e053-2a95a90ae391 | 2026-06-01 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | BENZOCAINE AND MENTHOL, UNSPECIFIED FORM | Reckitt Benckiser LLC | 6140d487-d87c-4954-9247-83492bcc5738 | 2026-05-27 | Warnings | M022 |
| Dolodent Maximum Strength | BENZOCAINE | Pharmadel LLC | 351ecc2b-cc1a-2bbf-e063-6394a90a5c14 | 2026-05-26 | Warnings | M022 |
| MOUTH ULCER | PANTHENOL | Guangzhou Shengli Shidai Cosmetics Co., Ltd. | 5264f81c-bffe-4f6d-e063-6394a90ae3bf | 2026-05-22 | Warnings | M022 |
| Sensitivity Relief Fluoride Free | POTASSIUM NITRATE | Health and Natural Beauty USA Corp | c23b2a83-ebc3-4bcf-a216-7693944dcfa0 | 2026-05-22 | 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 |