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 |
|---|---|---|---|---|---|---|
| Iolite | BENZOCAINE | Dharma Research, Inc. | e4b2d22b-00b3-45a6-9b7d-8ee719587059 | 2023-10-09 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | a0e284f6-292f-4231-8596-f7cee4e0a12f | 2023-10-09 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | fe92637a-c88a-f9dd-e053-6294a90a7fa3 | 2023-07-01 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | c979e958-2042-471a-bf03-e84e68620106 | 2023-06-20 | Warnings | M022 |
| Orajel Gum Pain 3X Medicated | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 9a1632ad-2b47-5653-e053-2995a90ae0d9 | 2023-01-20 | Warnings | M022 |
| KOLORZ TOPICAL ANESTHETIC TRIPLE MINT | BENZOCAINE | DMG AMERICA, LLC | 0f90b227-f938-4e1a-a79e-1967b1a0477e | 2021-10-01 | 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 |