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 |
|---|---|---|---|---|---|---|
| Medi-First Hydrocortisone 1% | HYDROCORTISONE ACETATE 1% | Unifirst First Aid Corporation | f2b46d69-1c21-5ae9-e053-2a95a90a60a9 | 2025-10-24 | Warnings | M017 |
| Extra Strength | MENTHOL AND METHYL SALICYLATE | Saje Natural Business Inc. | 87d872b3-3231-d0f2-e053-2995a90a9d98 | 2025-10-24 | Warnings | M017 |
| Coralite Muscle and Joint Pain Relief | CAMPHOR, MENTHOL, AND MEHTYL SALICYLATE | United Exchange Corporation | 78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc | 2025-10-24 | Warnings | M017 |
| Coralite Odor Free Pain Relief | LIDOCAINE | United Exchange Corporation | 7966d9f2-22f9-a900-e053-2991aa0aba55 | 2025-10-24 | Warnings | M017 |
| Signature Care Cold and Hot | MENTHOL, AND METHYL SALICYLATE | Safeway Inc. | ab201023-e3dc-52ec-e053-2995a90a1f18 | 2025-10-24 | Warnings | M017 |
| HealthWise Medicated Cold Hot 5% Patch | MENTHOL | Veridian Healthcare | 15aef56f-cd25-05ac-e063-6394a90a07bb | 2025-10-23 | Warnings | M017 |
| Alivio | LIDOCAINE | Amerise Pharmaceuticals LLC | eb3a98f1-c875-4f08-8b4b-44e22626b609 | 2025-10-23 | Warnings | M017 |
| Pain Relieveing Gel-Patch | LIDOCAINE | Bullet point LLC | 41d507c4-ad37-2686-e063-6394a90aae5b | 2025-10-23 | Warnings | M017 |
| ActivICE | MENTHOL | Medline Industries, LP | 98fa9a34-0e1e-0997-e053-2a95a90ac77d | 2025-10-23 | Warnings | M017 |
| Coralite Pain Relief Hot | MENTHOL AND CAPSAICIN | United Exchange Corporation | 78eb133d-01bb-6466-e053-2991aa0accc0 | 2025-10-23 | Warnings | M017 |
| Americaine | BENZOCAINE | Insight Pharmaceuticals LLC | 4fd14452-0285-40c4-b835-36935c2056b2 | 2025-10-23 | Warnings | M017 |
| zourunan PAIN RELIEF | PAIN RELIEF | Guchutang Biotechnology (Longyan) Co., Ltd | 41bc1c0c-63d5-0d41-e063-6394a90a341b | 2025-10-22 | Warnings | M017 |
| zourunan PAIN RELIEF | PAIN RELIEF | Guchutang Biotechnology (Longyan) Co., Ltd | 41bd0769-6ba0-d0d5-e063-6294a90af7c9 | 2025-10-22 | Warnings | M017 |
| Coralite Extra Strength Pain Relief Sleeve Knee | MENTHOL | United Exchange Corp. | aa5873bd-af64-41cc-8f16-7714c56bca96 | 2025-10-22 | Warnings | M017 |
| Family Care Muscle Rub | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | United Exchange Corp. | 63006bb5-76e8-eb64-e053-2991aa0a95ad | 2025-10-22 | Warnings | M017 |
| Winco Cold and Hot Medicated Patch Large | MENTHOL | WINCO FOODS, LLC | af0d86c4-f74e-2dbe-e053-2a95a90a74c1 | 2025-10-22 | Warnings | M017 |
| Coralite Cold and Hot | MENTHOL | United Exchange Corp. | 064a6149-a0e2-8a73-e063-6394a90a7953 | 2025-10-22 | Warnings | M017 |
| Topical Analgesic | MENTHOL | Youngevity International Inc. | b4693947-f5b3-6fd3-e053-2995a90ab581 | 2025-10-22 | Warnings | M017 |
| PAIN RELIEVING | LIDOCAINE | Medhome Pharma Inc | 41cb1135-84e0-0c9a-e063-6294a90ada96 | 2025-10-22 | Warnings | M017 |
| KINKAN | AMMONIA, CAMPHOR (NATURAL), MENTHOL | KINKANDO CO., LTD . | f2c0f3e1-792b-4798-bf6d-acd1bbefa261 | 2025-10-21 | 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 |