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 |
|---|---|---|---|---|---|---|
| Itch Eraser | DIPHENHYDRAMINE HCL | Tender Corporation d/b/a Adventure Ready Brands | 2204e135-6a23-68a2-e063-6394a90ac019 | 2025-11-18 | Warnings | M017 |
| Analgesic Balm | MENTHOL 10%, METHYL SALICYLATE 15% | Geri-Care Pharmaceuticals, Corp | c8594e10-661f-6ff3-e053-2995a90ab4fc | 2025-11-18 | Warnings | M017 |
| Mag 5 PT Cooling Formula Recovery Cream | MENTHOL | RENU LABORATORIES, LLC | a45cde67-64ec-643b-e053-2a95a90a10b6 | 2025-11-18 | Warnings | M017 |
| After Ivy Wipe | CAMPHOR | Tender Corporation d/b/a Adventure Ready Brands | 21d98018-826a-1d0d-e063-6294a90a0a71 | 2025-11-17 | Warnings | M017 |
| Itch Eraser Gel | DIPHENHYDRAMINE HCL | Tender Corporation d/b/a Adventure Ready Brands | 223c7cfd-6dc5-140a-e063-6394a90a8332 | 2025-11-17 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Kroger Co. | 6b3e7aac-395f-48cf-9c5e-f7e163724aef | 2025-11-17 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | HY-VEE, INC | 415ecfe9-3145-f23e-e063-6394a90adfd8 | 2025-11-17 | Warnings | M017 |
| AY BENDITO - CBD | CAMPHOR, MENTHOL | AY BENDITO INTERNATIONAL, INC | 04b1d605-60aa-56f4-e063-6294a90ae760 | 2025-11-17 | Warnings | M017 |
| AY BENDITO - CBD | CAMPHOR, MENTHOL | AY BENDITO INTERNATIONAL, INC | 0f1406fe-3a2f-bf36-e063-6294a90a7e5e | 2025-11-17 | Warnings | M017 |
| AY BENDITO CBD | MENTHOL, CAMPHOR | AY BENDITO INTERNATIONAL, INC | 30a1c6b7-e37e-32c2-e063-6394a90aa354 | 2025-11-17 | Warnings | M017 |
| ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000 | MENTHOL, CAMPHOR | Worldwide Cosmetics, Inc | 0816cc8f-8d0b-de27-e063-6294a90a8a9d | 2025-11-17 | Warnings | M017 |
| JUST CBD ROLL-ON COOLING | MENTHOL | Just Brands LLC | f6538e3e-4663-679c-e053-2995a90a87b5 | 2025-11-17 | Warnings | M017 |
| JUST CBD ROLL-ON WARMING | CAMPHOR | Just Brands LLC | f65455d7-04a9-6217-e053-2995a90a7c90 | 2025-11-17 | Warnings | M017 |
| JUST CBD - CBD AND THC ULTRA RELIEF | MENTHOL, CAMPHOR | Just Brands LLC | f664eb79-8897-3a49-e053-2995a90a37b4 | 2025-11-17 | Warnings | M017 |
| JUST CBD RELIEF SOOTHING | LIDOCAINE HCL | Just Brands LLC | f9aff6e7-5702-f61c-e053-6294a90aa66f | 2025-11-17 | Warnings | M017 |
| JUST CBD SOOTHING | MENTHOL, CAMPHOR | Just Brands LLC | 0abece07-976c-4881-e063-6294a90a5c1b | 2025-11-17 | Warnings | M017 |
| Blue-Emu Thrive Pain Relief Cream | TRIPELENNAMINE 0.5% | Kingsway Pharmaceuticals dba NFI, LLC | a4ba6787-c99b-4bf2-9f8f-e923ef976212 | 2025-11-14 | Warnings | M017 |
| CVS Cooling Patch | MENTHOL | CVS Pharmacy | 42d97e29-f32d-a31b-e063-6394a90a88d8 | 2025-11-14 | Warnings | M017 |
| Lidocaine | LIDOCAINE | Marlex Pharmaceuticals Inc | 4de2bc60-dc4a-4417-984f-eabab0e926a6 | 2025-11-14 | Warnings | M017 |
| EXTREME EMU | MENTHOL, METHYL SALICYLATE | Renu Laboratories, LLC | 4393b57b-1e70-b8dd-e063-6294a90ae748 | 2025-11-14 | 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 |