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 |
|---|---|---|---|---|---|---|
| AHLO PRO Healthy Gums | CETYLPYRIDINIUM CHLORIDE | Gervest USA Inc | 4f5a0ccb-26e5-ebb6-e063-6394a90abbc5 | 2026-04-13 | Warnings | M022 |
| Crest Scope Original Clean Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f1db6f4-acd7-a665-e063-6294a90a826b | 2026-04-10 | Warnings | M022 |
| Sore Throat | PHENOL GLYCERIN | Walgreens | 1e845299-178e-49ce-9d08-7e9d548a5a6d | 2026-04-09 | Warnings | M022 |
| Sore throat cherry | PHENOL | Walgreens | 67bed85e-e1e2-49ba-98d6-dfd4e1cd6856 | 2026-04-08 | Warnings | M022 |
| Health-Tec Topical Anesthetic | BENZOCAINE | Dental Health Products, Inc. | 5eb437c5-a2af-4c0d-b7b9-9ab7d093db85 | 2026-04-06 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Family Dollar (FAMILY WELLNESS) | 269b9e7f-c5c8-4023-a3ea-e39040ade271 | 2026-04-06 | Warnings | M022 |
| Health-Tec Topical Anesthetic | BENZOCAINE | Dental Health Products, Inc. | c3fb6705-c647-4fe6-9aca-29735d01d8ea | 2026-04-02 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Family Dollar (FAMILY WELLNESS) | f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea | 2026-04-01 | Warnings | M022 |
| CloSYS Silver Healthy Gums | CETYLPYRIDINIUM CHLORIDE | Rowpar Pharmaceuticals, Inc. | 11fd3f31-ee0c-43d2-a856-929d1298277c | 2026-04-01 | Warnings | M022 |
| Crest Pro-Health Bold Fresh Breath | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 5692c0ce-a914-08c4-e063-6394a90adf15 | 2026-04-01 | Warnings | M022 |
| Anticavity Fluoride | SODIUM FLUORIDE AND ACIDULATED PHOSPHATE | Family Dollar (FAMILY WELLNESS) | 1666fff6-9a8b-40f9-ae53-914152db386b | 2026-04-01 | Warnings | M022 |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | TWIN MED LLC | 10230c8a-e5e5-44f1-b41d-80930899d6b9 | 2026-03-31 | Warnings | M022 |
| Sootheez Birthday Cake | PECTIN | Primrose Candy Co. | 4e5d8234-0521-0c8a-e063-6294a90ae62d | 2026-03-31 | Warnings | M022 |
| Sootheez Watermelon Mint | PECTIN | Primrose Candy Co. | 4e5e4342-4647-ef25-e063-6394a90a1d13 | 2026-03-31 | Warnings | M022 |
| PERIOGELX | HYDROGEN PEROXIDE | PERIO PROTECT, LLC | 4e5a67a0-f989-50df-e063-6394a90aae73 | 2026-03-31 | Warnings | M022 |
| Periogel | HYDROGEN PEROXIDE | PERIO PROTECT, LLC | 1f9686b1-eac2-65b7-e063-6394a90a74fb | 2026-03-31 | Warnings | M022 |
| PERIOGELX | HYDROGEN PEROXIDE | PERIO PROTECT, LLC | 1f7ecd75-bb59-2f4f-e063-6294a90ace84 | 2026-03-31 | Warnings | M022 |
| Baza Protect | ZINC OXIDE AND DIMETHICONE | Coloplast Corp | ed63df26-3879-46df-8e09-10be569b25be | 2026-03-31 | Warnings | M022 |
| Benzocaine 20% | BENZOCAINE 20% | PAI Holdings, LLC dba PAI Pharma | 7fbce9a5-00dc-4a4a-8709-ab752bdf2f59 | 2026-03-25 | Warnings | M022 |
| Kroger Extra Whitening | FLUORIDE | Kroger | e704c690-1383-4cd6-be85-28bdd9ff936b | 2026-03-24 | 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 |