Orajel for Cold Sores Double Medicated, Cream
- Product NDC
- 10237-797
- 11-digit product format
- 102370797
- Labeler code
- 10237
- Product ID
- 10237-797_45382973-75d6-bf98-e063-6294a90a50fc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine and White Petrolatum
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-18
- Substance
- BENZOCAINE; PETROLATUM
- Active strength
- 200; 736.4 mg/g; mg/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- 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 for Cold Sores Double Medicated, Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 200 mg/g |
| PETROLATUM | 736.4 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| 4T6H12BN9U | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b8699a40-8464-ca02-e053-2995a90a4260 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-797-12 | Orajel for Cold Sores Double Medicated, Cream | 3.5 g in 1 TUBE | CREAM | 3.5 | 5 | |
| 10237-797-12 | Orajel for Cold Sores Double Medicated, Cream | 1 in 1 CARTON | CREAM | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10237-797 | ORAJEL FOR COLD SORES DOUBLE MEDICATED, CREAM (BENZOCAINE AND WHITE PETROLATUM) CREAM [CHURCH & DWIGHT CO., INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241129_b8699a40-8464-ca02-e053-2995a90a4260.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 |
|---|---|---|---|---|---|---|
| Biofreeze Professional | MENTHOL, UNSPECIFIED FORM | A-S Medication Solutions | cbeac814-59d8-4c13-8e73-bca66f797f8d | 2025-01-09 | Warnings | M017 |
| Bactine Max | LIDOCAINE | WellSpring Pharmaceutical Corporation | acd7ae37-7c42-4ec7-a2ef-42e7f628388d | 2025-01-08 | Warnings | M017 |
| THERABLAST MAXIMUM RELIEF | LIDOCAINE, MENTHOL | Releaf Technologies LLC | 09809985-3a88-9bb7-e063-6394a90a2f5f | 2025-01-08 | Warnings | M017 |
| ANTI ITCH | HYDROCORTISONE | Safeway | 0bfa1653-76b7-48ed-a896-a0b5fc3bd794 | 2025-01-08 | Warnings | M017 |
| Sting Relief Swab | BENZOCAINE | Epic Medical Supply Corp | 259fbfe4-d67c-ea1e-e063-6294a90a0fb0 | 2025-01-07 | Warnings | M017 |
| Sinsin Mulpas | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 22ea8a51-fdee-4650-abf8-f996268c9303 | 2025-01-07 | Warnings | M017 |
| SINSINPAP COOL | LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS | Sinsin Pharmaceutical Co., Ltd. | 9d47855f-ccb5-4557-a31a-a2b336fa9806 | 2025-01-07 | Warnings | M017 |
| Burn Jel | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | ff621b46-2342-41db-994d-851a09796d08 | 2025-01-06 | Warnings | M017 |
| Lidocare Arm, Neck, Leg | 4% LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 59a104ee-7034-99c3-e053-2991aa0a164c | 2025-01-06 | Warnings | M017 |
| Salonpas LIDOCAINE Pain Relieving | LIDOCAINE | Hisamitsu Pharmaceutical Co., Inc. | 4f3a438c-f378-4d2a-a95c-58e56cf1e797 | 2025-01-06 | Warnings | M017 |
| Lidocare 03 | 4% LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 416ebf5a-2efb-6d0b-e054-00144ff88e88 | 2025-01-06 | Warnings | M017 |
| AVCOO Pain Relief Roll-on | MENTHOL | ADP Health Limited | e0bb77b2-45ee-45fa-9659-9c7d99bb20dc | 2025-01-05 | Warnings | M017 |
| health and beyond BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 0b6bb3ed-50fb-40c4-acb6-ae3f16031531 | 2025-01-05 | Warnings | M017 |
| glo SKIN BEAUTY Remedy Gel | GLO SKIN BEAUTY REMEDY GEL | Hayden Caleel LLC | aa47ff08-07b3-4fd1-bae5-420e4b928f06 | 2025-01-05 | Warnings | M017 |
| Capsaicin 0.025% Cream | CAPSAICIN 0.025% | Puretek Corporation | 28f00df0-c416-f17b-e063-6294a90a5570 | 2025-01-02 | Warnings | M017 |
| AVON HeXashield Pain Relief for Muscle, Back and Joint Cream | CAMPHOR, MENTHOL, METHYL SALICYLATE | Tai Guk Pharm. Co., Ltd. | 8f29ffd7-48b9-109f-e053-2995a90ab215 | 2025-01-01 | Warnings | M017 |
| AVON HeXashield Arthritis Pain Relief Cream Capsaisin | CAPSAISIN | Tai Guk Pharm. Co., Ltd. | 8f286a9d-8765-21b3-e053-2a95a90ae43a | 2025-01-01 | Warnings | M017 |
| AVON HeXashield Anti Itch Cream with Healing Aloe | HYDROCORTISONE | Tai Guk Pharm. Co., Ltd. | 8f2aa11d-d794-6f3e-e053-2995a90a1d9d | 2025-01-01 | Warnings | M017 |
| HeXashield Anti Itch Cream with Healing Aloe | HYDROCORTISONE | Tai Guk Pharm. Co., Ltd. | b9d033f3-4d12-a2c8-e053-2995a90ac7f1 | 2025-01-01 | Warnings | M017 |
| Green Compass Reduce Pain Relief with Menthol | MENTHOL | Green Compass, Inc. | 0a0c212e-ae5d-8505-e063-6394a90af622 | 2025-01-01 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10237-797-12 | 10237079712 | 1 TUBE in 1 CARTON (10237-797-12) / 3.5 g in 1 TUBE | 1 tube | 2021-01-18 | 0000-00-00 | No | No | Current |