Orajel 4X Medicated Toothache and Gum PM Cream
- Product NDC
- 10237-889
- 11-digit product format
- 102370889
- Labeler code
- 10237
- Product ID
- 10237-889_5a1cdaf4-3389-280c-e063-6294a90ac70f
- 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
- BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
- Active strength
- 200; .2; 1.5; 2.6 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 PM Cream
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 200 mg/g |
| BENZALKONIUM CHLORIDE | .2 mg/g |
| ZINC CHLORIDE | 1.5 mg/g |
| MENTHOL, UNSPECIFIED FORM | 2.6 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| F5UM2KM3W7 | Internal UNII lookup |
| 86Q357L16B | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2751338 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5a1cdaf4-3388-280c-e063-6294a90ac70f | 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 |
|---|---|---|---|---|---|---|
| Sensitivity and Gum with Cavity Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Health and Natural Beauty USA Corp | 137d6935-19a3-499d-957c-820156eec7a5 | 2026-05-22 | Warnings | M022 |
| SEXYTEETH MINTY T00THPASTE | SEXYTEETH MINTY TOOTHPASTE | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 51d288c1-fe86-ffe1-e063-6394a90ab4c4 | 2026-05-14 | Warnings | M022 |
| Cepacol Extra Strength Sore Throat cherry | BENZOCAINE AND MENTHOL | Reckitt Benckiser LLC | 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 | 2026-05-12 | Warnings | M022 |
| Cepacol Extra Strength Sore Throat honey lemon | BENZOCAINE AND MENTHOL | Reckitt Benckiser LLC | d771095b-7de3-48f3-a125-8bc76e7d1778 | 2026-05-12 | Warnings | M022 |
| SEXYTEETH CHARCOAL T00THPASTE | SEXYTEETH CHARCOAL TOOTHPASTE | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 51ab8a9a-6c12-b13b-e063-6294a90ace2a | 2026-05-12 | Warnings | M022 |
| 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity | FLUORIDE | WHOLE FOODS | 25bc7ab1-116d-143a-e063-6394a90aa970 | 2026-05-04 | Warnings | M022 |
| Gingicaine Gel Strawberry | GINGICAINE GEL STRAWBERRY FLAVOR | Gingi-Pak a Division of the Belport | 2fd37612-a28b-3aa1-e054-00144ff8d46c | 2026-05-01 | Warnings | M022 |
| 3ECARE Dual formula WhiteningToothpaste Refill | SODIUM FLUORIDE | Hangzhou Namei Zhikang Technology Co., Ltd. | 501df1c7-4884-bb39-e063-6294a90aaf6a | 2026-04-23 | Warnings | M022 |
| Vicks VapoCOOL Severe Sugar-Free | MENTHOL | The Procter & Gamble Manufacturing Company | 1be4c73d-278f-7333-e063-6294a90a7d6d | 2026-04-23 | Warnings | M022 |
| Ora YoGu 4X Medicated Tooth and Gum Pain Reliever | MEDICATED TOOTH AND GUM PAIN RELIEVER | Kungpo Health Care & Herbal Center Inc | 1f10a72f-0b49-41cb-92f9-b0160d7664de | 2026-04-22 | Warnings | M022 |
| EverSmile AlignerFresh Enamel Guard | SODIUM FLUORIDE | Everbrands, Inc. | 7b3d0114-dac0-4370-8545-922ec018018e | 2026-04-21 | Warnings | M022 |
| PREOP | HYDROGEN PEROXIDE | Everbrands, Inc. | cc5cdd29-92c1-4ce0-997e-eb624b288b09 | 2026-04-20 | Warnings | M022 |
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | CVS | a7576238-e7c8-7e86-e053-2995a90aaeb5 | 2026-04-20 | Warnings | M022 |
| CVS Pharmacy Maximum Strength | BENZOCAINE | CVS Pharmacy | 92747826-cf58-4406-b3b5-12f7c7077c2c | 2026-04-20 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Family Dollar (FAMILY WELLNESS) | 9f991292-bbaa-4f4e-b2cb-059d1a04849e | 2026-04-20 | Warnings | M022 |
| Osstem S Sensitivity relief tooth | POTASSIUM NITRATE, SODIUM FLUORIDE | Osstem Pharma Co., Ltd | 4f8ab179-8f29-a7cf-e063-6294a90a0c22 | 2026-04-15 | Warnings | M022 |
| Crest Pro-Health Gum DetoxifyWinter Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f6db58f-0b09-d155-e063-6394a90ae658 | 2026-04-14 | Warnings | M022 |
| Lolleez Orange Mango | PECTIN | BFY LLC | 4f6dec8b-078a-f321-e063-6294a90a248c | 2026-04-14 | Warnings | M022 |
| Crest Pro-Health Gum Restore Smooth Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f6e3b36-e565-7d27-e063-6294a90ae5ac | 2026-04-14 | Warnings | M022 |
| Crest Pro-Health Nightly Bacteria Shield | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f6ec1e0-c6b5-226f-e063-6294a90a8f14 | 2026-04-14 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10237-889-25 | 10237088925 | 1 TUBE in 1 CARTON (10237-889-25) / 7 g in 1 TUBE | 1 tube | 2026-08-31 | No | No | Current |