Orajel Antiseptic Alcohol-Free Mouth Sore Rinse
- Product NDC
- 10237-784
- 11-digit product format
- 102370784
- Labeler code
- 10237
- Product ID
- 10237-784_27ea6bc8-f26b-d947-e063-6394a90ae2f5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrogen peroxide, Menthol
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-01
- Substance
- MENTHOL, UNSPECIFIED FORM; HYDROGEN PEROXIDE
- Active strength
- 1; 15 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 Antiseptic Alcohol-Free Mouth Sore Rinse
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 1 mg/mL |
| HYDROGEN PEROXIDE | 15 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
| BBX060AN9V | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2584344 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 99d47d6a-fa2e-d5ee-e053-2995a90aa11d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-784-16 | Orajel Antiseptic Alcohol-Free Mouth Sore Rinse | 473.2 mL in 1 BOTTLE | LIQUID | 473.2 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10237-784 | ORAJEL ANTISEPTIC ALCOHOL-FREE MOUTH SORE RINSE (HYDROGEN PEROXIDE, MENTHOL) LIQUID [CHURCH & DWIGHT CO., INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241129_99d47d6a-fa2e-d5ee-e053-2995a90aa11d.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 |
|---|---|---|---|---|---|---|
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | d22f7776-1b3c-4744-bcfe-8d9597218d73 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9c6a26e8-1253-49f7-9ce2-45c0d39f05c5 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 48178733-7433-41ec-b178-1314e0edab1a | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | af430cf4-f1b4-4b57-b8e3-87df96d655d3 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 2b089fec-cae3-4dc9-964d-d37f732a2f9f | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 6c137a93-4a34-4849-997f-bd0c572466ef | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | e8aa9709-e8f6-47a6-ab29-1fef2309786b | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 8c55b39c-8231-46a1-92ef-9fb4e3f40c1e | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9e82dc54-aeca-457f-b4b9-2f18cc269538 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 1a8f5964-770a-4d14-a7b6-18b5da9159b0 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 7209ceef-9842-400e-89fa-6f4f30053675 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 1bcb43d9-4e02-443a-8208-dd094f0203b0 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | fbac0cb4-0ccb-4d9d-9deb-a827c7bc8c66 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 891d54a9-5cbd-4897-90bf-ade9a3d046fc | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 59c03588-5421-4416-a25f-a4778b4d3ea3 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 68b643c0-a61e-4f68-9791-5f18f4fa8d81 | 2025-01-16 | Warnings | M022 |
| Top Quality Mfg. Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | e2e53f9c-5c5c-4771-8345-ff7dcc7bcc4e | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722cdf3-7671-eb27-e053-2a95a90a09c4 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722bf24-ae85-54f6-e053-2995a90a1d35 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721864d-0950-8379-e053-2a95a90a3bcb | 2025-01-16 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2584344 | hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical Solution | PSN | 99d47d6a-fa2e-d5ee-e053-2995a90aa11d | 6 |
| 2584344 | hydrogen peroxide 15 MG/ML / menthol 1 MG/ML Mucous Membrane Topical Solution | SCD | 99d47d6a-fa2e-d5ee-e053-2995a90aa11d | 6 |
| 2584344 | hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical Solution | SY | 99d47d6a-fa2e-d5ee-e053-2995a90aa11d | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10237-784-16 | 10237078416 | 473.2 mL in 1 BOTTLE (10237-784-16) | 473.2 ml | 2019-11-01 | 0000-00-00 | No | No | Current |