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 |
|---|---|---|---|---|---|---|
| TopCare Maximum Strength Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM | Topco Associates LLC | dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab | 2024-11-05 | Warnings | M017 |
| Aveeno Restorative Skin Therapy Itch Relief Balm | PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 61824ca7-a2d3-4830-b2bb-149a3222bfc8 | 2024-11-05 | Warnings | M017 |
| Aveeno Hydrocortisone ANTI-ITCH | HYDROCORTISONE | Kenvue Brands LLC | 233de4d7-e533-40cd-a5ed-e8b09abc626e | 2024-11-05 | Warnings | M017 |
| STING MASTER | LIDOCAINE HYDROCHLORIDE | Les Technologies Ptero, Inc | 94c6fd1f-9e74-420b-9d25-61b37953b838 | 2024-11-05 | Warnings | M017 |
| Alocane Emergency Burn | LIDOCAINE HYDROCHLORIDE | Quest Products, LLC. | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 2024-11-05 | Warnings | M017 |
| Alocane Max | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | 0a35ac19-6883-a733-e063-6294a90ad22d | 2024-11-05 | Warnings | M017 |
| Alocane Plus | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products, Inc. | cfe8114b-df65-064b-e053-2a95a90a33f6 | 2024-11-05 | Warnings | M017 |
| Alocane Botanicals | LIDOCAINE HYDROCHLORIDE | Quest Products, LLC. | 02a8e5c7-56f4-eb0d-e063-6294a90a80cd | 2024-11-05 | Warnings | M017 |
| Alocane Emergency Burn Pads | LIDOCAINE HYDROCHLORIDE | Quest Products, Inc. | fe58bb89-7216-4121-afd3-d1438bdfbfa2 | 2024-11-05 | Warnings | M017 |
| Licefreee AfterLice | PRAMOXINE HCI | Tec Laboratories Inc. | 06c4cc42-a215-3949-e063-6394a90a665e | 2024-11-05 | Warnings | M017 |
| Antibacterial Lidocaine Wound Gel | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | ASO LLC | cb9505b7-222d-3a24-e053-2a95a90a0b64 | 2024-11-05 | Warnings | M017 |
| TopCare Pain Relieving Analgesic | LIDOCAINE HYDROCHLORIDE | Topco Associates LLC | 6b4783e0-1987-4838-9e8c-b95426d62b28 | 2024-11-05 | Warnings | M017 |
| Eagle Green Balm | CAMPHOR MENTHOL | Borden Company (Private) Limited | 6f7a796b-a31c-0e60-e053-2a91aa0a022b | 2024-11-04 | Warnings | M017 |
| Muscular Balm | CAPSAICIN MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | ed79f14e-6b3d-4bf2-9c34-d019c1ba2582 | 2024-11-04 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE | A-S Medication Solutions | 3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3 | 2024-11-04 | Warnings | M017 |
| Walgreens Ice Blue Pain Relieving Topical Analgesic | MENTHOL, UNSPECIFIED FORM | Walgreen Company | 1c0ee442-ffd2-4f6c-aab2-f70e295378ad | 2024-11-04 | Warnings | M017 |
| Walgreen Cool n Heat Maximum Strength Pain Relieving | MENTHOL, UNSPECIFIED FORM | Walgreen Company | d5c79476-dde8-4a85-8878-bc2ac3a3d70b | 2024-11-04 | Warnings | M017 |
| LIDOCAINE | LIDOCAINE | STRATUS PHARMACEUTICALS INC | 87a4f559-a4f6-4b9f-98de-b55b073a11c6 | 2024-11-01 | Warnings | M017 |
| Walgreens Nerve Pain Relieving Topical Analgesic | LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM | Walgreen Company | 83849eca-e02f-4b43-b3a7-b25e987e08a8 | 2024-10-31 | Warnings | M017 |
| Sanar Naturals Arnica White | CAMPHOR | Sanvall Enterprises, Inc | 192039a2-aed6-821b-e063-6394a90a7f29 | 2024-10-31 | 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 |