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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide | HYDROGEN PEROXIDE | CVS PHARMACY, INC | 3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb2 | 2025-12-17 | Warnings | M022 |
| Sore Throat | PHENOL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 9128d59c-6fa9-4358-865a-802257a9bd25 | 2025-12-16 | Warnings | M022 |
| S.T.37 | HEXYLRESORCINOL | NUMARK BRANDS, INC | 7d7acca2-aa8a-5272-e813-faab039cc798 | 2025-12-15 | Warnings | M022 |
| Esunix Oral Bacteriostatic Gel | CETYLPYRIDINIUM CHLORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f4ee467-8142-8cb7-e063-6394a90aa7f7 | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated For Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999851ac-925c-7d1f-e053-2a95a90a240b | 2025-12-12 | Warnings | M022 |
| Orajel 3X Medicated For Toothache and Gum | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 99a2b061-0875-59a4-e053-2995a90ab373 | 2025-12-12 | Warnings | M022 |
| Orajel Antiseptic Rinse For All Mouth Sores | HYDROGEN PEROXIDE AND MENTHOL | Church & Dwight Co., Inc. | 06188d36-0d60-6ae6-e054-00144ff8d46c | 2025-12-12 | Warnings | M022 |
| Orajel 3X Medicated For All Mouth Sores | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 99b589ac-9833-fb60-e053-2995a90a0935 | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated For Toothache and Gum, Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999aa7b9-bf9e-9285-e053-2a95a90a345b | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated PM For Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999cff2b-c23e-5abe-e053-2a95a90a7569 | 2025-12-12 | Warnings | M022 |
| Vicks Formula 44 Cough Drops | MENTHOL | The Procter & Gamble Manufacturing Company | bb9e483e-095d-8a42-e053-2a95a90ad8d6 | 2025-12-12 | Warnings | M022 |
| Benzoin Compound Tincture | BENZOIN RESIN | Humco Holding Group, Inc. | a893a232-2ea8-4e0d-8cbf-7f5040b3be2e | 2025-12-11 | Warnings | M022 |
| Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 456d45e8-bf6d-31c4-e063-6394a90a5c00 | 2025-12-10 | Warnings | M022 |
| Oral pain relief | BENZOCAINE | ALAINA HEALTHCARE PRIVATE LIMITED | d98c1b2f-fe75-4d52-b082-1abb7628c59e | 2025-12-09 | Warnings | M022 |
| HEB Sensitive Extra Whitening Twin | SODIUM FLUORIDE | HEB | 41d5ae3e-51c1-263b-e063-6394a90a3312 | 2025-12-08 | Warnings | M022 |
| CankerMelts | BENZOCAINE | Quest Products, LLC | 070dae82-14c2-66d2-e063-6394a90ab259 | 2025-12-04 | Warnings | M022 |
| Sore Throat ReadyInCase | PHENOL | P & L Development, LLC | 2fb3d17e-8ca3-4edb-8b82-4b484f42616e | 2025-12-03 | Warnings | M022 |
| Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 44f2b66a-26ae-1044-e063-6394a90a9ab6 | 2025-12-02 | Warnings | M022 |
| Sensodyne Fresh Clean | STANNOUS FLUORIDE | Haleon US Holdings LLC | 2d433ac1-3ddf-a2f4-e063-6394a90a91f8 | 2025-12-01 | Warnings | M022 |
| Walgreens Saline | NASAL | WALGREEN COMPANY | 147e45c8-1e71-4c06-89f1-42e9f9683366 | 2025-12-01 | 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 |