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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 872365ca-0c6b-550a-e053-2a91aa0ab25a | 2024-06-14 | Warnings | M022 |
| Amosan Oral Wound Cleanser Spearmint | SODIUM PERBORATE MONOHYDRATE | Vintage Brands Limited | 7ac6c649-758f-4128-9920-466c0967b86a | 2024-05-21 | Warnings | M022 |
| Sensodyne | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 9e8e7b9f-3ccd-4935-b886-93f3a5045b67 | 2024-05-15 | Warnings | M022 |
| Sensodyne Extra Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 2024-05-15 | Warnings | M022 |
| Attitude Adult Fluoride-free - Sensitive - Spearmint | POTASSIUM NITRATE | 9055-7588 Qubec Inc. DBA Attitude | 46d5c908-f0e3-444c-9d96-461feef39137 | 2024-05-14 | Warnings | M022 |
| sensodyne | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 16225f06-1d40-416a-aaec-7890e398fe4b | 2024-05-13 | Warnings | M022 |
| Sore Throat Cherry | PHENOL | QUALITY CHOICE (Chain Drug Marketing Association) | 9162ae27-ddbb-4336-9655-487995919de4 | 2024-05-01 | Warnings | M022 |
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE AND POTASSIUM NITRATE | 9055-7588 Quebec Inc. DBA Attitude | 42b79ec5-f37f-4dc9-9631-c8b1c153fe88 | 2024-04-26 | Warnings | M022 |
| Quality Choice Oral Pain Relief | BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1% | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | 162702b4-4bf7-8868-e063-6294a90a5921 | 2024-04-15 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 9991de96-99a1-42f0-9ddd-e530ca9ceab1 | 2024-04-11 | Warnings | M022 |
| Aquafresh Extreme Clean Pure Breath Action | SODIUM FLUORIDE | Haleon US Holdings LLC | 462eb309-deca-4464-b13a-7ae314e53ede | 2024-04-08 | Warnings | M022 |
| Sore Throat Cherry | PHENOL | Family Dollar (FAMILY WELLNESS) | 7806fac7-736e-44b0-baa2-42feb7237417 | 2024-03-27 | Warnings | M022 |
| Sucrets | DYCLONINE HCL, MENTHOL, AND PECTIN | Insight Pharmaceuticals LLC | 2a2839ea-11d3-4390-930d-0da912a9c6f5 | 2024-03-20 | Warnings | M022 |
| Sucrets Sore Throat Wild Cherry | DYCLONINE HYDROCHLORIDE | Insight Pharmaceuticals LLC | da4967c7-ee18-42e7-8c97-8919f3bb1b7d | 2024-03-20 | Warnings | M022 |
| NATEAN Clean plus Sensitivity Relief | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | cea6f992-8a44-4eb8-baea-97b7b181b227 | 2024-03-19 | Warnings | M022 |
| NATEAN Clean and Whiten | SODIUM FLUORIDE | Haleon US Holdings LLC | 71b95962-2693-49f5-94d2-f2a035b5e0c8 | 2024-03-19 | Warnings | M022 |
| SENSODYNE Sensitivity and Gum Mint | STANNOUS FLUORIDE | Haleon US Holdings LLC | ed093acd-255c-40ff-a010-d276f5844453 | 2024-03-07 | Warnings | M022 |
| SENSODYNE Sensitivity Gum and Enamel Mint | STANNOUS FLUORIDE | Haleon US Holdings LLC | d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2 | 2024-03-07 | Warnings | M022 |
| Sensodyne True white | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 671f8f45-389c-4375-be43-f5500ee21a0e | 2024-03-07 | Warnings | M022 |
| Sensodyne Pronamel Strong and Bright Enamel Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | be1ae382-0e01-4db8-90d7-fdadec2ff861 | 2024-03-06 | 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 |