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 |
|---|---|---|---|---|---|---|
| Epsom Salts | MAGNESIUM SULFATE | International Wholesale Inc. | e5f3edc2-1b79-533a-e053-2a95a90ae9b6 | 2024-12-19 | Warnings | M017 |
| Leader | LIDOCAINE HCL | Cardinal Health | cea6bd2d-a265-1209-e053-2995a90ab0a5 | 2024-12-19 | Warnings | M017 |
| Rugby Anti-Itch | CAMPHOR, MENTHOL | RUGBY LABORATORIES | 99d8ad9e-46ec-15fc-e053-2995a90a0d17 | 2024-12-19 | Warnings | M017 |
| DCH Calaspray Itch Relief | PRAMOXINE HCL 1%, ZINC ACETATE 0.1% | Derma Care Research Labs, LLC | fda2afaf-3cd0-92b3-e053-6394a90a7493 | 2024-12-19 | Warnings | M017 |
| DCH Nerve Pain Relief Roll-On | LIDOCAINE HCL 4%, MENTHOL 1% | Derma Care Research Labs, LLC | ff32cbb2-79eb-9158-e053-6394a90ac357 | 2024-12-19 | Warnings | M017 |
| DCH Burn Relief | LIDOCAINE, 0.5% | Derma Care Research Labs | ffd7be08-0510-dfcb-e053-6394a90ad286 | 2024-12-19 | Warnings | M017 |
| DCH Arthritis Pain Relief Roll-On | CAPSAISIN 0.1% | Derma Care Research Labs, LLC | fda0d359-95eb-8b38-e053-6294a90a7b88 | 2024-12-19 | Warnings | M017 |
| DCH Pain Relieving | MENTHOL 2% | Derma Care Research Labs, LLC | ff49ee63-6a87-c7a7-e053-6294a90a77a3 | 2024-12-19 | Warnings | M017 |
| Warrior Pain Relief Roll-On Maximum Strength | LIDOCAINE HCL 4% | Derma Care Research Labs, LLC | dd80e560-6467-2166-e053-2995a90a88a8 | 2024-12-19 | Warnings | M017 |
| DCH Labs Cool and Heat Roll-On | MENTHOL 16% | Derma Care Research Labs, LLC | d35d7720-44ce-3624-e053-2995a90a7fb4 | 2024-12-19 | Warnings | M017 |
| Dr Goldsons Pain | MENTHOL 8%, METHYL SALICYLATE 30% | Derma Care Research Labs, LLC | fb34b0d3-ccc0-305e-e053-6394a90a231d | 2024-12-19 | Warnings | M017 |
| Warrior Pain Relieving | CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30% | Derma Care Research Labs, LLC | dd06af3c-5452-9759-e053-2a95a90afc21 | 2024-12-19 | Warnings | M017 |
| Warrior Burn Relief Aloe Maximum Strength | LIDOCAINE HCL 4% | Derma Care Research Labs, LLC | ec6efa4b-dcbe-1c2b-e053-2995a90ae043 | 2024-12-19 | Warnings | M017 |
| DCH Arthritis Relief | TROLAMIN SALICYLATE 10% | Derma Care Research Labs, LLC | ff31e515-5780-b77d-e053-6394a90af6b9 | 2024-12-19 | Warnings | M017 |
| DCH Pain Relief | LIDOCAINE 4% | Derma Care Research Labs, LLC | 00efda74-d434-04be-e063-6294a90a6d98 | 2024-12-19 | Warnings | M017 |
| Dollar General Cold Therapy Pain Relief | MENTHOL 5% | Dolgencorp, LLC | ff3284d1-e73c-93bf-e053-6294a90aaf4e | 2024-12-19 | Warnings | M017 |
| Dollar General Pain Relieving Patch with Lidocaine | LIDOCAINE | DOLGENCORP, LLC | 55828cd1-3a1e-48ac-bb01-4c50b96d09a2 | 2024-12-19 | Warnings | M017 |
| DCH Nerve Pain Relief | LIDOCAINE 4%, MENTHOL 1% | Derma Care Research Labs, LLC | 00db480a-e510-a64d-e063-6394a90a4695 | 2024-12-19 | Warnings | M017 |
| Pain, Burn, and Itch Relief | BENZOCAINE 20%, MENTHOL 0.5% | Derma Care Research Labs, LLC | fd9fe09f-3ae9-c5f5-e053-6394a90ad691 | 2024-12-19 | Warnings | M017 |
| DCH Cooling Pain Relief | MENTHOL 4% | Derma Care Research Labs, LLC | 00ed3175-c3ba-6545-e063-6394a90acfd1 | 2024-12-19 | 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 |