Orajel 3X Medicated For Toothache and Gum
- Product NDC
- 10237-790
- 11-digit product format
- 102370790
- Labeler code
- 10237
- Product ID
- 10237-790_45c2eb22-063f-1dd9-e063-6394a90aae42
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine, Menthol, Zinc chloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-01
- Substance
- MENTHOL; BENZOCAINE; ZINC CHLORIDE
- Active strength
- 2.6; 200; 1.5 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
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 10237-790 | 10237-790-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 10237-790 | 10237-790-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 10237-790 | 10237-790-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
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 3X Medicated For Toothache and Gum
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 2.6 mg/g |
| BENZOCAINE | 200 mg/g |
| ZINC CHLORIDE | 1.5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
| U3RSY48JW5 | Internal UNII lookup |
| 86Q357L16B | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2362013 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 99a2b061-0875-59a4-e053-2995a90ab373 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-790-12 | Orajel 3X Medicated For Toothache and Gum | 3.5 g in 1 TUBE | GEL | 3.5 | 11 | |
| 10237-790-12 | Orajel 3X Medicated For Toothache and Gum | 1 in 1 CARTON | GEL | 1 | 11 | |
| 10237-790-25 | Orajel 3X Medicated For Toothache and Gum | 1 in 1 CARTON | GEL | 1 | 11 | |
| 10237-790-25 | Orajel 3X Medicated For Toothache and Gum | 7 g in 1 TUBE | GEL | 7 | 11 | |
| 10237-790-42 | Orajel 3X Medicated For Toothache and Gum | 1 in 1 CARTON | GEL | 1 | 11 | |
| 10237-790-42 | Orajel 3X Medicated For Toothache and Gum | 11.9 g in 1 TUBE | GEL | 11.9 | 11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10237-790 | ORAJEL 3X MEDICATED FOR TOOTHACHE AND GUM (BENZOCAINE, MENTHOL, ZINC CHLORIDE) GEL [CHURCH & DWIGHT CO., INC.] | 10 | Current NDC, Legacy NDC, 6 package rows | 20241129_99a2b061-0875-59a4-e053-2995a90ab373.zip |
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 |
|---|---|---|---|---|---|---|
| Chloraspetic | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | 2b1808b2-2574-4ab8-a762-5733251848ce | 2024-10-25 | Warnings | M022 |
| Chloraseptic Warming Sore Throat | PHENOL | Prestige Brands Holdings, Inc. | a197fab2-70ce-4a6c-9add-29d7368a75c5 | 2024-10-25 | Warnings | M022 |
| Gly-Oxide | CARBAMIDE PEROXIDE | Medtech Products Inc. | 086a0b82-e947-41c9-89e7-ba06483960c9 | 2024-10-25 | Warnings | M022 |
| CHLORASEPTIC | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | d500f423-b9f2-4d98-8f2a-8bab7c05737c | 2024-10-25 | Warnings | M022 |
| CHLORASEPTIC | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | b30e4b32-89dd-4e53-81d5-1415105361d4 | 2024-10-25 | Warnings | M022 |
| Finafta MultiOral | BENZOCAINE | Efficient Laboratories Inc. | 28c5a993-fb5f-4091-af15-32ccae4b9a7d | 2024-10-14 | Warnings | M022 |
| Rexall Sensitive Freshmint | POTASSIUM NITRATE, SODIUM FLUORIDE | Old East Main CO. | 7e715bb9-666e-4de4-ba70-1c84f5243443 | 2024-10-14 | Warnings | M022 |
| Rexall Sensitive Extra Whitening | POTASSIUM NITRATE, SODIUM FLUORIDE | Old East Main CO. | 2daf18a3-f71e-4585-8128-4663eff7eb6d | 2024-10-14 | Warnings | M022 |
| Anadent Kanka Gel | BENZOCAINE | BELMORA LLC | e0f73d78-5db1-43b4-8f58-e5410ca4560f | 2024-10-04 | Warnings | M022 |
| Listerine Cool Mint Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Navajo Manufacturing Company Inc. | f5f26e2f-8a1f-4687-e053-2a95a90ae378 | 2024-10-03 | Warnings | M022 |
| Colgate Great Regular Flavor | SODIUM MONOFLUOROPHOSPHATE | Navajo Manufacturing Company Inc. | f89bf259-b738-8229-e053-6394a90a0c59 | 2024-10-03 | Warnings | M022 |
| Colgate Total SF Clean Mint | STANNOUS FLUORIDE | Navajo Manufacturing Company Inc. | f71c53e0-e2dd-16f9-e053-6394a90accff | 2024-10-03 | Warnings | M022 |
| Crest Pro Health | CETYLPYRIDINIUM CHLORIDE | Navajo Manufacturing Company Inc. | 65bf17a9-21ad-27cb-e053-2991aa0afc40 | 2024-10-02 | Warnings | M022 |
| Sensodyne Pronamel Gentle Whitening Advanced | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 94e07979-943b-45bb-8e2b-90d686f3692e | 2024-09-04 | Warnings | M022 |
| Sensodyne Pronamel Gentle Whitening Advanced Plus | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | 6eb304dd-2a24-4fa0-9d39-71264e88dd16 | 2024-08-29 | Warnings | M022 |
| Sensodyne Pronamel Clinical Enamel Strength Deep Clean | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | cfda7efa-86fa-470d-a79f-81907e31778a | 2024-08-14 | Warnings | M022 |
| Sensodyne Pronamel Kids Bubble Twist | SODIUM FLUORIDE | Haleon US Holdings LLC | e403529a-0fac-4dab-b75c-46906add096b | 2024-08-13 | Warnings | M022 |
| Calcium Carbonate Assorted Flavors | ANTACID TABLETS | NuCare Pharmaceuticals,Inc. | af10dfb6-fef3-3410-e053-2995a90a9130 | 2024-07-17 | Warnings | M022 |
| SENSODYNE Advanced Whitening Plus | POTASSIUM NITRATE | Haleon US Holdings LLC | f757ccdd-b316-4799-a34a-10edbb73da6b | 2024-07-12 | Warnings | M022 |
| dentalux SENSITIVE ANTI-CAVITY FLUORIDE | POTASSIUM NITRATE, SODIUM FLUORIDE | Lidl US, LLC | baef7f15-8082-4e61-8c08-8beda8ad40c0 | 2024-07-03 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2362013 | benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Gel | PSN | 99a2b061-0875-59a4-e053-2995a90ab373 | 11 |
| 2362013 | benzocaine 0.2 MG/MG / menthol 0.0026 MG/MG / zinc chloride 0.0015 MG/MG Oral Gel | SCD | 99a2b061-0875-59a4-e053-2995a90ab373 | 11 |
| 2362013 | benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Gel | SY | 99a2b061-0875-59a4-e053-2995a90ab373 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10237-790-12 | 10237079012 | 1 TUBE in 1 CARTON (10237-790-12) / 3.5 g in 1 TUBE | 1 tube | 2019-11-01 | 0000-00-00 | No | No | Current |
| 10237-790-25 | 10237079025 | 1 TUBE in 1 CARTON (10237-790-25) / 7 g in 1 TUBE | 1 tube | 2019-11-01 | 0000-00-00 | No | No | Current |
| 10237-790-42 | 10237079042 | 1 TUBE in 1 CARTON (10237-790-42) / 11.9 g in 1 TUBE | 1 tube | 2019-11-01 | 0000-00-00 | No | No | Current |