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 |
|---|---|---|---|---|---|---|
| SENSODYNE Rapid Relief | STANNOUS FLUORIDE | Haleon US Holdings LLC | f9589e7c-c5ca-4465-8d37-47ad6c69249f | 2024-03-06 | Warnings | M022 |
| SENSODYNE Repair and Protect Extra Fresh | STANNOUS FLUORIDE | Haleon US Holdings LLC | 34260c69-d829-46c0-b12a-5136ee073ba1 | 2024-03-06 | Warnings | M022 |
| AQUAFRESH SENSITIVE MAXIMUM STRENGTH | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 76adbccb-0812-4407-a6fc-a57e6f144fbb | 2024-03-05 | Warnings | M022 |
| SENSODYNE Advanced Whitening | POTASSIUM NITRATE | Haleon US Holdings LLC | a06e2549-3c4e-4818-b53e-1dea6828219f | 2024-03-04 | Warnings | M022 |
| Sensodyne Extra Whitening Cool Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | c977f2c4-e0f3-44d2-aa7a-845f0583af3e | 2024-03-04 | Warnings | M022 |
| Sensodyne Natural white | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 911ac7e4-2b92-43d5-af0b-b5f741b088fb | 2024-03-04 | Warnings | M022 |
| Sensodyne Nourish Healthy White | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | aca38560-2fd7-47be-9e93-2abc3214e856 | 2024-03-04 | Warnings | M022 |
| Sensodyne Nourish Gently Soothing | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 5403ab67-532c-4bdf-9b06-07b1866f37f1 | 2024-03-04 | Warnings | M022 |
| SENSODYNE PRONAMEL Active Shield Fresh Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | e8684615-f544-4871-b935-0a0f93639d7d | 2024-03-04 | Warnings | M022 |
| Sensodyne Pronamel Gentle Whitening Fresh Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 3dfa6827-3aae-4f19-93f6-2ded2faf2ddd | 2024-03-04 | Warnings | M022 |
| Made by Dentists Sensitive and Whitening Fresh Mint | POTASSIUM NITRATE, SODIUM FLUORIDE | MADE BY DENTISTS INC | 0d379c26-69ff-4666-9ad5-7618f0bd139f | 2024-02-27 | Warnings | M022 |
| Polident ProPartial | STANNOUS FLUORIDE | Haleon US Holdings LLC | 557eeb32-64f4-41e8-ada4-91bd39ae2920 | 2024-02-07 | Warnings | M022 |
| SENSODYNE PRONAMEL Daily Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | edffce4d-108b-4ffd-9adf-e12cb42ffddd | 2024-01-24 | Warnings | M022 |
| Peppermint Twist | FLUORIDE | Caldwell Health LLC | 4b28cdd1-0dba-42f5-a9e8-06d9e75b2396 | 2024-01-17 | Warnings | M022 |
| The Natural Dentist Groovy Grape | FLUORIDE | Caldwell Consumer Health LLC | 087abbed-1f58-4b45-a76b-a950fa81c18c | 2024-01-16 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | Pharma Nobis, LLC | e42fccc2-1b4f-e7f3-e053-2a95a90aef39 | 2023-12-26 | Warnings | M022 |
| Sunmark Benzoin Compound Tincture | BENZOIN RESIN | Strategic Sourcing Services LLC | 0c96d810-83dc-47d3-9a75-63a79feaad0a | 2023-12-19 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | Humco Holding Group, Inc. | b33b5896-673b-498c-8a58-76ece8552f7a | 2023-12-15 | Warnings | M022 |
| Povidone Iodine | POVIDONE IODINE ORAL RINSE 0.5% | Humco Holding Group, Inc. | b83dbdd1-ff63-caf8-e053-2a95a90a5764 | 2023-12-15 | Warnings | M022 |
| Moon Whitening Gel Anticavity | SODIUM FLUORIDE | Moon Oral Care, LLC | 0c556a29-a697-3a66-e063-6394a90abfee | 2023-12-12 | 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 |