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 Cold and Hot Medicated | MENTHOL | Topco Associates LLC | 8739aedd-165c-5ae0-e053-2a91aa0afcd0 | 2025-10-31 | Warnings | M017 |
| CVS Medicated Heat 1 ct | CAPSAICIN | CVS Pharmacy, Inc. | d41dce5b-e698-4930-8869-040b2a973f25 | 2025-10-31 | Warnings | M017 |
| Coralite Medicated Heat | CAPSAICIN | United Exchange Corp. | a0b89c7e-80bc-43c4-840c-5fd567f60b21 | 2025-10-31 | Warnings | M017 |
| Dragon with Arnical Pain Relief | MENTHOL | Genomma Lab USA Inc. | b4cbb7b6-cb71-9721-e053-2995a90a2b2c | 2025-10-31 | Warnings | M017 |
| Hydrocortisone Anti-Itch | HYDROCORTISONE | Universal Distribution Center LLC | 186afb11-06b6-4bfa-e063-6294a90aefc6 | 2025-10-30 | Warnings | M017 |
| Gemachlich ZuHause NEUROPATHY SOLID Ointment. | GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT. | Guangdong Quadrant Ecological Technology Co., Ltd. | 425b1b9d-c33a-05e9-e063-6394a90a97a6 | 2025-10-30 | Warnings | M017 |
| Gemachlich ZuHause NEUROPATHY Spray. | GEMACHLICH ZUHAUSE NEUROPATHY SPRAY. | Guangdong Quadrant Ecological Technology Co., Ltd. | 425b8259-af38-8d68-e063-6394a90a1120 | 2025-10-30 | Warnings | M017 |
| Family Care Muscle and Joint | MENTHOL | United Exchange Corp. | 959af9f4-7188-91a1-e053-2995a90a4665 | 2025-10-30 | Warnings | M017 |
| CVS Maximum Strength Boil Relief | BENZOCAINE | CVS Pharmacy, Inc. | 0761b866-af34-42bd-adc9-3d229170d01c | 2025-10-30 | Warnings | M017 |
| CVS Cold and Hot | MENTHOL | CVS Pharmacy | a44ca52d-fec8-0e8c-e053-2995a90a2e60 | 2025-10-30 | Warnings | M017 |
| CVS CAPSAICIN | CAPSAICIN | CVS PHARMACY | 9b551fe3-3842-482a-9042-63de5ad39884 | 2025-10-30 | Warnings | M017 |
| TopCare Health Pain Relief | MENTHOL, CAMPHOR, AND METHYL SALICYLATE | Topco Associates LLC | dac364ef-6dcd-3fc6-e053-2a95a90a9bb2 | 2025-10-30 | Warnings | M017 |
| Calamine Plus | CALAMINE PLUS PRAMOXINE HCL | AmerisourceBergen Drug Corporation | f161e151-4fab-2fbc-e053-2a95a90a5437 | 2025-10-30 | Warnings | M017 |
| Lidocaine | BURN RELIEF | Perrigo Direct | c7b50f14-3481-9ebd-e053-2995a90afe1c | 2025-10-30 | Warnings | M017 |
| Lipoflavonoid Ear Pain Kids Relief Drops | LIPOFLAVONOID EAR PAIN KIDS RELIEF DROPS | Clarion Brands LLC | 4265361b-5526-c3e0-e063-6394a90a1777 | 2025-10-30 | Warnings | M017 |
| Diphenhydramine HCl and Zinc Acetate | EXTRA STRENGTH ITCH RELIEF | HEB | 2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f | 2025-10-30 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE SPRAY | Meijer Distribution Inc. | 28daaf97-b0b3-7a54-e063-6294a90a23f1 | 2025-10-30 | Warnings | M017 |
| Calamine Plus | CALAMINE PLUS PRAMOXINE HCL | Meijer Distribution Inc. | 03c46823-0b1f-4101-e063-6294a90aaf94 | 2025-10-30 | Warnings | M017 |
| Extra Strength Itch Relief | DIPHENHYDRAMINE HCL AND ZINC ACETATE | Meijer Distribution Inc | 02f9e270-6047-83b6-e063-6394a90afc27 | 2025-10-30 | Warnings | M017 |
| Muscle Rub Pain Reliever Gel | MENTHOL, UNSPECIFIED FORM | Universal Distribution Centre LLC | 18536e21-afc3-8447-e063-6394a90aabae | 2025-10-30 | 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 |