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 |
|---|---|---|---|---|---|---|
| OWELL NATURALS Deep Penetrating Pain Relief | MENTHOL | OWELL NATURALS BRAND, LLC | b36eb017-ed8d-476e-994b-22b275e00543 | 2024-01-02 | Warnings | M017 |
| Dibucaine | DIBUCAINE 1% | Trifecta Pharmaceuticals USA LLC | e8a56651-a292-7609-e053-2a95a90a7c36 | 2024-01-02 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Trifecta Pharmaceuticals USA, LLC. | 44d17651-a31b-64ca-e054-00144ff8d46c | 2024-01-02 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | e0a13344-5493-eb51-e053-2995a90a8183 | 2024-01-02 | Warnings | M017 |
| Sumifun Knee Relieve Patch | KNEE RELIEVE PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0e031aa5-edf4-8c9d-e063-6394a90afee3 | 2024-01-02 | Warnings | M017 |
| OKeeffes Healthy Feet | ALLANTOIN, LIDOCAINE | The Gorilla Glue Company/O'Keeffe's Company | d73709db-3932-3c56-e053-2995a90a7d0a | 2024-01-01 | Warnings | M017 |
| PERSONAL CARE ICE COLD | MENTHOL | NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. | 1994356c-e347-5b7d-e063-6394a90a476c | 2024-01-01 | Warnings | M017 |
| Dendracin Neurodendraxcin | METHYL SALICYLATE, MENTHOL AND CAPSAICIN | Proficient Rx LP | 7e765fc1-74c6-4af3-a9cf-05b57011d7d8 | 2024-01-01 | Warnings | M017 |
| CeraVe Developed with Dermatologists Itch Relief Moisturizing | PRAMOXINE HYDROCHLORIDE | L'Oreal USA Products Inc | c6a0880e-fc16-46e9-8314-c56c9d15bf31 | 2023-12-31 | Warnings | M017 |
| CeraVe Developed with Dermatologists Anti Itch | HYDROCORTISONE | L'Oreal USA Products Inc. | 8d65e945-2557-486f-9279-ecbaa08f31c4 | 2023-12-31 | Warnings | M017 |
| Nighttime Sleep-Aid Non-Habit Forming | DIPHENHYDRAMINE HCI | AptaPharma Inc. | ed0ba7aa-e794-43da-b576-6b9945bf7477 | 2023-12-30 | Warnings | M017 |
| Sting-Kill | BENZOCAINE AND MENTHOL | RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH | b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701 | 2023-12-29 | Warnings | M017 |
| Maybelline New York Baby Lips Dr Rescue Medicated Balm | MENTHOL | L'Oreal USA Products Inc | 2f7b8221-66f6-4aed-8359-318cfc656a72 | 2023-12-28 | Warnings | M017 |
| Equate Cortisone | HYDROCORTISONE 1% | Walmart Inc | 027fae33-93a0-a61f-e063-6294a90a990f | 2023-12-27 | Warnings | M017 |
| Walgreens Cool n Heat Lidocaine | LIDOCAINE HCL 4% | Walgreens Co | 0681c6c5-5a8b-ea9e-e063-6394a90a83bc | 2023-12-27 | Warnings | M017 |
| EXTRA STRENGTH WAL-DRYL ITCH RELIEF | DIPHENHYDRAMINE, ZINC ACETATE | WALGREEN CO | 681cf1af-2cc3-4e6d-b76f-f00731ea3e12 | 2023-12-27 | Warnings | M017 |
| XRay Pain Relief | MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE | Genomma Lab USA | 5244ddee-fd9e-4df3-8fb3-b16aa321a316 | 2023-12-27 | Warnings | M017 |
| Camphor Spirit | CAMPHOR 10% | Pharma Nobis, LLC | e42fbe63-b01c-4f85-e053-2a95a90a5143 | 2023-12-26 | Warnings | M017 |
| Equate Calaspray | PRAMOXINE HCL 1%, ZINC ACETATE 0.1% | Walmart Inc | 027ed5ab-05ec-569f-e063-6394a90abbc3 | 2023-12-26 | Warnings | M017 |
| EXTERNAL ANALGESIC | CAMPHOR, CAPSICUM, MENTHOL | Hmong 21 | 3b6155a5-51aa-2780-e054-00144ff8d46c | 2023-12-26 | 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 |