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 |
|---|---|---|---|---|---|---|
| pain relief roll-on | LIDOCAINE 4% | Bionpharma Inc. | f607b6dc-8d13-604a-e053-2995a90a59ab | 2024-12-23 | Warnings | M017 |
| Veneno de Abeja Aceite De Vibora Brand | METHYL SALICYLATE | Miramar Cosmetics, Inc DBA Miramar Lab | a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825 | 2024-12-23 | Warnings | M017 |
| Itch Relief | HYDROCORTISONE 1% | Trifecta Pharmaceuticals USA LLC | af5daf6c-bcad-8ebf-e053-2a95a90af1b0 | 2024-12-20 | Warnings | M017 |
| Pain Itch Relief | LIDOCAINE HCI | Trifecta Pharmaceutical USA LLC | f40b19a8-795c-f514-e053-2a95a90a6d15 | 2024-12-20 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | 44d3638d-f29b-0e01-e054-00144ff88e88 | 2024-12-20 | Warnings | M017 |
| Rhuli Gel | CAMPHOR, MENTHOL | Trifecta Pharmaceuticals USA, LLC. | 4fbb3c23-ed47-336e-e054-00144ff8d46c | 2024-12-20 | Warnings | M017 |
| Hydrocortisone Cream with Aloe | HYDROCORTISONE | Rugby Laboratories | 132982ea-cce6-687c-e063-6294a90a4632 | 2024-12-20 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Pharmacy Value Alliance LLC | 9bb98452-a605-5c20-e053-2995a90a1ea7 | 2024-12-20 | Warnings | M017 |
| DCH Cooling Pain Relief | MENTHOL 10.5% | Derma Care Research Labs, LLC | 00dcdae0-c744-8402-e063-6294a90a12f8 | 2024-12-20 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Pharmacy Value Alliance LLC | ab95e606-69f0-1d58-e053-2a95a90a073b | 2024-12-20 | Warnings | M017 |
| Itch Relief Cream | ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2% | Pharmacy Value Alliance LLC | 37fe6d82-adee-4f58-e054-00144ff88e88 | 2024-12-20 | Warnings | M017 |
| Warrior First Aid Anti Itch | DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1% | Derma Care Research Labs, LLC | ec6e9a5b-c61d-a385-e053-2995a90ac936 | 2024-12-20 | Warnings | M017 |
| DCH Burn Relief | LIDOCAINE HCL | Derma Care Research Labs, LLC | ff227154-cf3b-9796-e053-6294a90a5535 | 2024-12-20 | Warnings | M017 |
| Outback Pain Relief | CAMPHOR 6%, MENTHOL 16% | Derma Care Research Labs, LLC | c238c930-2012-2d48-e053-2a95a90a8a4a | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | LIDOCAINE HCL 4% | Meijer | f31b11ed-2ff9-5cfc-e053-2a95a90af2ca | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | MENTHOL 10.5% | Meijer | bed81975-bd63-cf5b-e053-2995a90ac5fa | 2024-12-20 | Warnings | M017 |
| Mirakel Pain and Itch Relief | BENZOCAINE 20%, RESORCINOL 3% | Sanvio, Inc. | ed34d728-0275-e209-e053-2995a90a93ff | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | LIDOCAINE 4% | Meijer | bed67c31-c479-6f9b-e053-2a95a90a5516 | 2024-12-20 | Warnings | M017 |
| Blue-Emu Ultra with Hemp Seed | TROLAMINE SALICYLATE | Kingsway Pharmaceuticals dba NFI, LLC | 80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9 | 2024-12-20 | Warnings | M017 |
| Epsom Salts | MAGNESIUM SULFATE | International Wholesale Inc. | e4d9bc32-ac85-349f-e053-2995a90a032f | 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 |