Orajel Medicated for Toothache and Gum, Liquid
- Product NDC
- 10237-796
- 11-digit product format
- 102370796
- Labeler code
- 10237
- Product ID
- 10237-796_557be35d-65ca-291a-e063-6294a90aac6e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine and Menthol
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-08-07
- Substance
- BENZOCAINE; MENTHOL, UNSPECIFIED FORM
- Active strength
- 200; 1 mg/mL; mg/mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [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 Medicated for Toothache and Gum, Liquid
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 200 mg/mL |
| MENTHOL, UNSPECIFIED FORM | 1 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2110600 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ac3d605d-241d-1a6f-e053-2a95a90ae391 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-02-05 | Orajel Medicated for Toothache and Gum, Liquid |
| 2024-02-05 | Orajel 2x Medicated for Toothache and Gum, Liquid |
| 2023-01-30 | Orajel Medicated for Toothache and Gum, Liquid |
| 2023-01-30 | Orajel 2x Medicated for Toothache and Gum, Liquid |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-796-45 | Orajel Medicated for Toothache and Gum, Liquid | 13.3 mL in 1 BOTTLE, GLASS | LIQUID | 13.3 | 5 | |
| 10237-796-45 | Orajel Medicated for Toothache and Gum, Liquid | 1 in 1 CARTON | LIQUID | 1 | 5 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Avant | BENZOCAINE | Dharma Research, Inc. | baf7d184-07ed-4491-a1fc-9a377b4b0110 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | 033034af-c86c-4dbf-90eb-009c117024c6 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | 658ada18-2334-4b4e-b08e-702fa127aa14 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | cad932e5-8d7f-4f20-b1c2-febd328152f0 | 2023-10-11 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 2c9519ab-320d-49da-9deb-97a6168fb088 | 2023-10-10 | Warnings | M022 |
| Ioline | BENZOCAINE | Dharma Research, Inc. | b862c974-c024-42c3-986e-b65069437c7b | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 651ea978-081d-4c59-b177-6049a69d9415 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | db763237-2910-45b9-be72-da092edc951b | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 34316f93-10b4-41cc-8654-625283f0044c | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 142a8824-657e-492a-8e5a-b15eb73383c9 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 414cbec9-94e2-4bca-908b-1e79f8db0b27 | 2023-10-10 | Warnings | M022 |
| Sore throat cherry | PHENOL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | de634cf1-ed39-4d8a-8855-006c69b7aee9 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | e4b2d22b-00b3-45a6-9b7d-8ee719587059 | 2023-10-09 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | a0e284f6-292f-4231-8596-f7cee4e0a12f | 2023-10-09 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | fe92637a-c88a-f9dd-e053-6294a90a7fa3 | 2023-07-01 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | c979e958-2042-471a-bf03-e84e68620106 | 2023-06-20 | Warnings | M022 |
| Orajel Gum Pain 3X Medicated | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 9a1632ad-2b47-5653-e053-2995a90ae0d9 | 2023-01-20 | Warnings | M022 |
| KOLORZ TOPICAL ANESTHETIC TRIPLE MINT | BENZOCAINE | DMG AMERICA, LLC | 0f90b227-f938-4e1a-a79e-1967b1a0477e | 2021-10-01 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2110600 | benzocaine 20 % / menthol 0.1 % Mucous Membrane Topical Solution | PSN | ac3d605d-241d-1a6f-e053-2a95a90ae391 | 5 |
| 2110600 | benzocaine 200 MG/ML / menthol 1 MG/ML Mucous Membrane Topical Solution | SCD | ac3d605d-241d-1a6f-e053-2a95a90ae391 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10237-796-45 | 10237079645 | 1 BOTTLE, GLASS in 1 CARTON (10237-796-45) / 13.3 mL in 1 BOTTLE, GLASS | 2020-08-07 | 0000-00-00 | No | No | Current |