Benzo-Jel
- Product NDC
- 0404-0033
- 11-digit product format
- 004040033
- Labeler code
- 0404
- Product ID
- 0404-0033_2acfde41-0b79-ccba-e063-6294a90ac911
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- DENTAL
- Labeler
- Henry Schein Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-05-01
- Substance
- BENZOCAINE
- Active strength
- 200 mg/g
- 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
- Benzo-Jel
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 200 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fb38b10d-0faf-403c-9921-d4f6b0f6aa55 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0404-0033-30 | Benzo-Jel | 30 g in 1 JAR | GEL | 30 | 4 |
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 |
|---|---|---|---|---|
| 1053444 | BENZO-JEL 20 % Oral Gel | PSN | fb38b10d-0faf-403c-9921-d4f6b0f6aa55 | 4 |
| 238910 | benzocaine 20 % Oral Gel | PSN | fb38b10d-0faf-403c-9921-d4f6b0f6aa55 | 4 |
| 1053444 | benzocaine 0.2 MG/MG Oral Gel [Benzo-Jel] | SBD | fb38b10d-0faf-403c-9921-d4f6b0f6aa55 | 4 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | fb38b10d-0faf-403c-9921-d4f6b0f6aa55 | 4 |
| 1053444 | Benzo-Jel 0.2 MG/MG Oral Gel | SY | fb38b10d-0faf-403c-9921-d4f6b0f6aa55 | 4 |
| 1053444 | Benzo-Jel 20 % Oral Gel | SY | fb38b10d-0faf-403c-9921-d4f6b0f6aa55 | 4 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | fb38b10d-0faf-403c-9921-d4f6b0f6aa55 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0404-0033-30 | 00404003330 | 30 g in 1 JAR (0404-0033-30) | 30 g | 2018-06-01 | 0000-00-00 | No | No | Current |