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 |
|---|---|---|---|---|---|---|
| Mineral Ice Methol Pain Relief | MENTHOL 10.5 % | Sunflora Inc | 6ddd9e97-f717-4d5a-9658-26449a3cc831 | 2026-07-02 | Warnings | M017 |
| Burn Relief | LIDOCAINE | AmerisourceBergen Drug Corporation | 7d898e33-ded7-c9b9-e053-2a91aa0adf7c | 2026-07-01 | Warnings | M017 |
| Desert Harvest Releveum with Lidocaine | LIDOCAINE HYDROCHLORIDE | Desert Harvest, Inc | 9ad514ab-a6bd-4564-8ba3-0149032ebf36 | 2026-07-01 | Warnings | M017 |
| CVS No Mess Cortisone | HYDROCORTISONE | Natural Essentials, Inc. | 558c94ec-95f1-eb98-e063-6394a90a1e72 | 2026-07-01 | Warnings | M017 |
| MUSCLE EASE | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | 03fff4bf-04ed-49a6-b40f-4d98c2b42f69 | 2026-07-01 | Warnings | M017 |
| OrthoNesic Pain Relieving Gel | MENTHOL, CAMPHOR | Blaine Labs Inc. | 122f60c2-f8df-4625-8bb8-a2244a261b5d | 2026-07-01 | Warnings | M017 |
| Desert Harvest RELEVEUM | LIDOCAINE | Desert Harvest Inc. | 5d9010ec-d482-44ff-ba27-3bfec5a241c6 | 2026-06-30 | Warnings | M017 |
| Promescent | LIDICAINE | Absorption | 5b508238-3be7-4b0d-bf35-51de79f58f55 | 2026-06-30 | Warnings | M017 |
| Lidovyx | LIDOCAINE 4% | V2 Pharma LLC | 4465eb60-a617-4608-9504-8b3b4c64f49e | 2026-06-30 | Warnings | M017 |
| Dr.Johnes Lidocaine 4% Topical Analgesic Cream | LIDOCAINE HCL,MENTHOL | Dr.Johnes LLC | 6144708d-4b0f-4f0d-88e3-6925ba2d004d | 2026-06-29 | Warnings | M017 |
| Dr Sabharwals | METHYL SALICYLATE 10% GEL PATCH | Dr. Sabharwal's Wound Care | 4a7790bb-25cb-72b8-e063-6294a90a6b9c | 2026-06-29 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Target Corporation | 36602b7a-99c0-f6a4-e063-6294a90a8758 | 2026-06-29 | Warnings | M017 |
| FIRST SHIELD | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Unishield | f86f7446-b741-9f40-e053-6394a90a4422 | 2026-06-29 | Warnings | M017 |
| MQ Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5560cdab-cee8-f6ec-e063-6294a90ad024 | 2026-06-29 | Warnings | M017 |
| GNP Lidocaine Maximum Strength | LIDOCAINE HCL | AMERISOURCE BERGEN | 9f559c20-c9ac-e480-e053-2a95a90a8fce | 2026-06-29 | Warnings | M017 |
| NUMBING | LIDOCAINE | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 5553385d-c1e6-1242-e063-6394a90aa5a7 | 2026-06-28 | Warnings | M017 |
| MOROVAN | LIDOCAINE | HONG KONG UNORDERED TRADING CO., LIMITED | 550c8d2d-e0d7-1531-e063-6394a90a374d | 2026-06-25 | Warnings | M017 |
| Marie Originals Medicated Outdoor Anti Itch | HYDROCORTISONE SPRAY | Marie's Original Formulas, LLC | 5517ee5f-1c51-cfd6-e063-6294a90af56f | 2026-06-25 | Warnings | M017 |
| Marie Originals Medicated Outdoor Anti Itch | HYDROCORTISONE SPRAY | Marie's Original Formulas LLC | 55188ede-68cd-fcc6-e063-6394a90a5c58 | 2026-06-25 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1% | NuCare Pharmaceuticals, Inc. | 54f07a23-213f-ca46-e063-6394a90a0034 | 2026-06-24 | 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 |