Orajel 4X Medicated Toothache and Gum Cream
- Product NDC
- 10237-888
- 11-digit product format
- 102370888
- Labeler code
- 10237
- Product ID
- 10237-888_5a1c7fdc-8ac7-d3b8-e063-6294a90a63c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-08-31
- Substance
- BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL, UNSPECIFIED FORM; ZINC CATION
- Active strength
- .2; 200; 2.6; 1.5 mg/g; mg/g; mg/g; mg/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Orajel 4X Medicated Toothache and Gum Cream
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZALKONIUM CHLORIDE | .2 mg/g |
| BENZOCAINE | 200 mg/g |
| MENTHOL, UNSPECIFIED FORM | 2.6 mg/g |
| ZINC CATION | 1.5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F5UM2KM3W7 | Internal UNII lookup |
| U3RSY48JW5 | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
| 13S1S8SF37 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2751338 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5a1c82b4-02b3-d456-e063-6294a90a16bb | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Patterson Dental Topical Anesthetic | BENZOCAINE | Patterson Dental | 72fd2232-cd5a-4e25-b139-522b589c4472 | 2025-01-08 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 42521b29-67e4-4a16-848d-7e6ba4a7ece2 | 2025-01-08 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals LLC | 723da3ae-3f1f-4962-920b-f2a30c8c3253 | 2025-01-08 | Warnings, Adverse reactions | M022 |
| V34 Colour Corrector | V34 COLOUR CORRECTOR | Jiangxi Dentalbright Technology Co., Ltd | 2b2a0b47-7628-4b85-e063-6294a90a45a0 | 2025-01-07 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | bc2e7ac3-f9e4-49cc-9f0c-6fe94479314d | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | fb38b10d-0faf-403c-9921-d4f6b0f6aa55 | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | a9dc2245-c029-4453-bfc5-8fb899873c34 | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | ba49a18d-8568-421b-a495-8fee863c9757 | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | c9b584d9-7407-445a-b084-926250af9f8e | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | 4aa6eec8-394a-4ecb-8173-66561fd64913 | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | 25c99ae3-90f4-4a63-924d-f810b3ba6e60 | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | 84e8d5c8-2a35-4179-9a9c-9a4a52c2cae6 | 2025-01-03 | Warnings | M022 |
| Prevention Oncology Mouth Rinse | GLYCERIN | Prevention Health Sciences, Inc. | 1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c | 2025-01-01 | Warnings | M022 |
| Prevention Mouth Sore Rinse | HYDROGEN PEROXIDE | Prevention Health Sciences, Inc. | 2eae61e4-1800-5fa6-e063-6394a90a9583 | 2025-01-01 | Warnings | M022 |
| Antiseptic Lil Drug Store Products | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Lil' Drug Store Products, Inc | dca36a30-2c9f-4d0b-be88-b45c7046f509 | 2024-12-31 | Warnings | M022 |
| Sensodyne Clinical White Intensive Clean | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | f193ec40-032f-42c7-81f1-029ec8989374 | 2024-12-31 | Warnings | M022 |
| TeethWhitening Kit | TEETHWHITENING KIT | Jiangxi Dentalbright Technology Co., Ltd. | 29393313-217a-dc3a-e063-6294a90addb1 | 2024-12-20 | Warnings | M022 |
| Breezers Cool Berry | PECTIN | Mondelez Global LLC | b31d0078-21d7-4d18-a8d3-7c8d48d6d004 | 2024-12-20 | Warnings | M022 |
| Breezers Creamy Strawberry | PECTIN | Mondelez Global LLC | 777fd6db-f129-4489-8312-4b1aca94878e | 2024-12-20 | Warnings | M022 |
| Halls Breezers Sugar Free Cool Berry | PECTIN | Mondelez Global LLC | dd1b4b17-4f73-4052-9589-d5fd6bb059bb | 2024-12-20 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10237-888-33 | 10237088833 | 1 TUBE in 1 CARTON (10237-888-33) / 9.4 g in 1 TUBE | 1 tube | 2026-08-31 | No | No | Current |