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 |
|---|---|---|---|---|---|---|
| Sensitive Whitening Tooth-paste | POTASSIUM NITRATE, SODIUM FLUORIDE | Meijer, Inc. | c25b6a95-e604-48e3-bc55-595969d1ce9b | 2025-12-23 | Warnings | M022 |
| parodontax Active Gum Repair | STANNOUS FLUORIDE | Haleon US Holdings LLC | b51ccdd9-c0af-4caa-ad97-ad1d1423b76b | 2025-12-22 | Warnings | M022 |
| parodontax Complete Protection | STANNOUS FLUORIDE | Haleon US Holdings LLC | 59bb84d6-6fd3-4586-bccf-7dc45cbbb39c | 2025-12-22 | Warnings | M022 |
| parodontax Complete Protection | STANNOUS FLUORIDE | Haleon US Holdings LLC | f6912712-ce9b-44aa-8953-b9a8d420f458 | 2025-12-22 | Warnings | M022 |
| parodontax Active Gum Repair Whitening | STANNOUS FLUORIDE | Haleon US Holdings LLC | 817e804c-e55e-4d77-9ab9-ff54ae794725 | 2025-12-22 | Warnings | M022 |
| parodontax Active Gum Repair Breath Freshener | STANNOUS FLUORIDE | Haleon US Holdings LLC | addcb1e2-24b9-4367-adf3-6806e2439a80 | 2025-12-22 | Warnings | M022 |
| parodontax | STANNOUS FLUORIDE | Haleon US Holdings LLC | 0f07aa1a-97be-44af-92d8-a10777e24e0a | 2025-12-22 | Warnings | M022 |
| R B one | PHOSPHATIDYLSERINE, ZINC OXIDE | NPG Bio Pharmaceuticals Co.,Ltd. | 410c40fd-cf94-0301-e063-6294a90ae2de | 2025-12-18 | Warnings | M022 |
| Dem Zero | PHOSPHATIDYLSERINE, MAGNESIUM OXIDE | NPG Bio Pharmaceuticals Co.,Ltd. | 411f1a0f-ed02-cc78-e063-6394a90a0aec | 2025-12-18 | Warnings | M022 |
| Res B one | PHOSPHATIDYLSERINE, ZINC OXIDE | NPG Bio Pharmaceuticals Co.,Ltd. | 21469f58-1d70-774f-e063-6294a90af039 | 2025-12-18 | Warnings | M022 |
| Alzh L | PHOSPHATIDYLSERINE, MAGNESIUM OXIDE | NPG Bio Pharmaceuticals Co.,Ltd. | 41056de0-aaa2-01bb-e063-6394a90af7b8 | 2025-12-18 | Warnings | M022 |
| Lemon | GLYCERIN | TwinMed LLC | fc88eec0-c66c-5d6d-e053-6294a90a13d2 | 2025-12-18 | Warnings | M022 |
| CloSYS | HYDROGEN PEROXIDE | Rowpar Pharmaceuticals, Inc. | 299fc7b1-af6d-4bf9-810f-d35283423fe2 | 2025-12-17 | Warnings | M022 |
| Ipana 20% Benzocaine Topical | BENZOCAINE | Maxill Inc. | c13761e0-d45d-4e0f-ac41-428e005f96bb | 2025-12-17 | Warnings | M022 |
| Ipana 20% Benzocaine Topical | BENZOCAINE | Maxill Inc. | 6dca566b-cb6a-43c4-b6e2-f2bad77fb932 | 2025-12-17 | Warnings | M022 |
| Ipana 20% Benzocaine Topical | BENZOCAINE | Maxill Inc. | f36bb9bd-e9bc-4f35-a388-e0ffadbce6ab | 2025-12-17 | Warnings | M022 |
| Ipana 20% Benzocaine Topical | BENZOCAINE | Maxill Inc. | 7ede08e5-2dfe-4183-905d-28d1cea42407 | 2025-12-17 | Warnings | M022 |
| Ipana 20% Benzocaine Topical | BENZOCAINE | Maxill Inc. | 9de36e4f-f966-4a58-b4bf-9ac3b86b3f09 | 2025-12-17 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | CVS PHARMACY, INC | 3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb2 | 2025-12-17 | Warnings | M022 |
| Sore Throat | PHENOL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 9128d59c-6fa9-4358-865a-802257a9bd25 | 2025-12-16 | 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 |