Orajel 4X Medicated Toothache and Gum
- Product NDC
- 10237-887
- 11-digit product format
- 102370887
- Labeler code
- 10237
- Product ID
- 10237-887_5a1bd621-3a4b-2fa1-e063-6294a90a5b7c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-08-31
- Substance
- BENZOCAINE; MENTHOL, UNSPECIFIED FORM; BENZALKONIUM CHLORIDE; ZINC CHLORIDE
- Active strength
- 200; 7.6; .2; 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
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 200 mg/g |
| MENTHOL, UNSPECIFIED FORM | 7.6 mg/g |
| BENZALKONIUM CHLORIDE | .2 mg/g |
| ZINC CHLORIDE | 1.5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
| F5UM2KM3W7 | Internal UNII lookup |
| 86Q357L16B | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2751340 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5a1b4133-0eac-2f8f-e063-6394a90af8f6 | 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 |
|---|---|---|---|---|---|---|
| CrystLCare Regeneration Plus | POTASSIUM NITRATE, SODIUM FLUORIDE | GreenMark Biomedical Inc. | 4f86d0a0-d73e-5605-e063-6394a90adb38 | 2026-09-14 | Warnings | M022 |
| Opalescence Whitening Sensitivity Relief | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | 44e94663-895b-67da-e063-6394a90a5fe6 | 2026-09-09 | Warnings | M022 |
| Opalescence Sensitivity Relief Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | b5176a84-76a3-4ad0-a2e2-4997a12da9a5 | 2026-09-09 | Warnings | M022 |
| Opal by Opalescence Sensitivity | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | 5ffc0d14-0290-47bb-90e5-90a25a5acc28 | 2026-09-09 | Warnings | M022 |
| Saline | NASAL | Raritan Pharmaceuiticals Inc | 4b178e4e-a10f-4b75-8140-1f7548e203ad | 2026-09-09 | Warnings | M022 |
| SORE THROAT | PHENOL | Raritan Pharmaceuticals Inc | 43ce374a-824c-4034-bf04-c351b4d8015b | 2026-09-08 | Warnings | M022 |
| Colgate Optic White Stain Fighter Sens Relief | SODIUM FLUORIDE | Colgate-Palmolive Company | 6ec2fff7-df44-4302-be2d-97946c6cd66a | 2026-09-08 | Warnings | M022 |
| DRx Choice Sore Throat Menthol Flavor | PHENOL | RARITAN PHARMACEUTICALS INC | e3269b12-5c05-45a6-81f2-65d9f016c3aa | 2026-09-08 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 0733015b-e81a-4a62-82ad-dacaf3f163cb | 2026-09-02 | Warnings | M022 |
| KROGER Saline | NASAL | KROGER COMPANY | c84b242b-f46e-4ea8-a3c1-109a47644646 | 2026-09-02 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | ceb125d9-8c1b-498c-b0f0-f18756ede442 | 2026-09-01 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1c82b4-02b3-d456-e063-6294a90a16bb | 2026-08-31 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum PM Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1cdaf4-3388-280c-e063-6294a90ac70f | 2026-08-31 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT | HEXYLRESORCINOL | Reckitt Benckiser LLC | 91cd2964-5d83-4e40-bc18-e3e5462f454a | 2026-08-31 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | HEXYLRESORCINOL | Reckitt Benckiser LLC | 4c150222-06ea-4fcf-967f-84e19846bd66 | 2026-08-31 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1b4133-0eac-2f8f-e063-6394a90af8f6 | 2026-08-28 | Warnings | M022 10237-887 |
| LUDENS SUGAR FREE WILD CHERRY THROAT | PECTIN | Prestige Brands Holdings, Inc. | 274fc80c-e5b2-41c7-a119-287d6e8a2258 | 2026-08-28 | Warnings | M022 |
| Medline Peroxi Fresh Mouthwash | HYDROGEN PEROXIDE | Medline Industries, LP | ec7a9240-6c66-4471-b8b6-776e08a14fbc | 2026-08-27 | Warnings | M022 |
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | M022 |
| Tumeez Organic Apple | CALCIUM CARBONATE | BFY LLC | f561685a-5260-59c6-e053-2a95a90ae206 | 2026-08-25 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10237-887-25 | 10237088725 | 1 TUBE in 1 CARTON (10237-887-25) / 7 g in 1 TUBE | 1 tube | 2026-08-31 | No | No | Current |