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 |
|---|---|---|---|---|---|---|
| RELISPRAY NATURAL PAIN RELIEF | MENTHOL | Midas-Care Pharmaceuticals, Pvt. Ltd | adc8a43c-19a1-4eb3-9820-b63f7b5e91ea | 2025-10-30 | Warnings | M017 |
| Aveeno Anti-Itch Concentrated | ZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 07f4d4d0-9cee-46c3-bc71-2024abd31c9e | 2025-10-29 | Warnings | M017 |
| zourunan Relieve itching cream ANTIFUNGAL | RELIEVE ITCHING CREAM | Guchutang Biotechnology (Longyan) Co., Ltd | 41bb9ced-dde4-2998-e063-6394a90a8159 | 2025-10-29 | Warnings | M017 |
| zourunan Intensive healing lotion. for ECZEMA | INTENSIVE HEALING LOTION | Guchutang Biotechnology (Longyan) Co., Ltd | 41bad9f3-f1a7-e92c-e063-6394a90ad0ba | 2025-10-29 | Warnings | M017 |
| Aromalief Pain Relief Cream Orange Ginger | MENTHOL | Marketites LLC | 9e8d3611-ef1b-4ac6-e053-2995a90af28a | 2025-10-29 | Warnings | M017 |
| Aromalief Calming Pain Relief Cream Lavender | MENTHOL | Marketites LLC | b8197d52-ccfb-b008-e053-2995a90a0a53 | 2025-10-29 | Warnings | M017 |
| Aromalief Cozy Vanilla Pain Relief Cream | MENTHOL | Marketites LLC | 3634e55e-8c62-a782-e063-6394a90a6508 | 2025-10-29 | Warnings | M017 |
| BENOVA PAIN AND ITCH RELIEF | MENTHOL, 0.11% | BENOVA RX LLC | 42513ee2-8b40-a9f3-e063-6394a90a9386 | 2025-10-29 | Warnings | M017 |
| Burn Relief | LIDOCAINE | CVS Pharmacy | 7e9285fd-26d5-3eac-e053-2991aa0ae2db | 2025-10-29 | Warnings | M017 |
| Coralite Ultra Strength Pain Relief | CAMPHOR MENTHOL | United Exchange Corp. | 44ecf959-cc07-4adc-a500-075b2ee69548 | 2025-10-29 | Warnings | M017 |
| GoodSense Pain Relief | LIDOCAINE | Geiss, Destin & Dunn, Inc | 826f8da4-8468-ea0a-e053-2991aa0a66cb | 2025-10-28 | Warnings | M017 |
| CALMADOL | CAMPHOR, MENTHOL, METHYL SALICYLATE | GRANDALL DISTRIBUTING, LLC | 31b7f84e-8b66-4d31-8e9c-279d0af2fe64 | 2025-10-28 | Warnings | M017 |
| XRay DOL | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | Genomma Lab USA, Inc. | e07fef46-68d9-769c-e053-2a95a90aa065 | 2025-10-28 | Warnings | M017 |
| CVS Medicated Heat | CAPSICUM EXTRACT | CVS Pharmacy | 81cd1019-93a6-311b-e053-2991aa0a7997 | 2025-10-28 | Warnings | M017 |
| Foster and Thrive | LIDOCAINE | STRATEGIC SOURCING SERVICES, LLC | f950b072-d978-b629-e053-6394a90abfaf | 2025-10-28 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Premier Brands of America, Inc. | d3452573-f91f-f157-e053-2a95a90a1ad8 | 2025-10-27 | Warnings | M017 |
| PR | MENTHOL | Amphp, Inc | 6f5b9e08-c445-4fac-e053-2a91aa0aa737 | 2025-10-27 | Warnings | M017 |
| Lidocaine | BURN RELIEF | Foodhold USA | b25dc0df-02d0-41ac-b36c-2c04baa77ef2 | 2025-10-27 | Warnings | M017 |
| Menthol | MAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREE | FSA Store Inc. | fb3548c8-f202-dc50-e053-6394a90a5b30 | 2025-10-27 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE CONTINUOUS SPRAY | Premier Brands of America, Inc. | d344f68b-9b62-3029-e053-2995a90a1665 | 2025-10-27 | 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 |