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 |
|---|---|---|---|---|---|---|
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | Kroger | a8c5090a-24f9-4e73-e053-2a95a90acca0 | 2025-11-14 | Warnings | M017 |
| PM Toothache Relief | BENZOCAINE | CVS | 0a5a8cd0-d680-8a0f-e063-6294a90aa65c | 2025-11-14 | Warnings | M017 |
| PM Toothache Relief | BENZOCAINE | Walgreens | e816f742-fba9-3c12-e053-2a95a90a192f | 2025-11-14 | Warnings | M017 |
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | Walgreens | a71c2092-4ece-b82e-e053-2995a90ac933 | 2025-11-14 | Warnings | M017 |
| After Bite Outdoor | DIPHENHYDRAMINE HCL | Tender Corporation d/b/a Adventure Ready Brands | 22b891a9-6386-dee1-e063-6394a90a5c2f | 2025-11-14 | Warnings | M017 |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 8f8f53e3-fe31-e7b5-e053-2995a90a710d | 2025-11-14 | Warnings | M017 |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 9984a510-30be-4013-e053-2995a90a841e | 2025-11-14 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Kroger | 3f881349-fcdd-e276-e063-6394a90ae49e | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 434cb8b2-a996-5360-e063-6394a90ada03 | 2025-11-13 | Warnings | M017 |
| Rapid Relief | COLD RELIEF PATCH 5% MENTHOL | RAPID AID VIET NAM COMPANY LIMITED | 4360e3ec-7a4b-b28e-e063-6294a90a0bd6 | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG | RAPID AID VIET NAM COMPANY LIMITED | 4360e3be-0ec4-cd57-e063-6394a90aca63 | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 43616ad7-58bb-e5ad-e063-6394a90a192b | 2025-11-13 | Warnings | M017 |
| 4x Medicated Severe Toothache and Gum Gel | BENZALKONIUM CHLORIDE | Meijer | 97ce7890-5093-1763-e053-2a95a90afae7 | 2025-11-13 | Warnings | M017 |
| Pain Reliever | CAMPHOR, MENTHOL | Kool 'N Fit Inc. | 2253f6bd-5707-b993-e063-6394a90aa74a | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 4360e0d1-46cd-ab4b-e063-6394a90a55e1 | 2025-11-12 | Warnings | M017 |
| CVS Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | CVS | 8723e097-296f-784a-e053-2991aa0a552e | 2025-11-12 | Warnings | M017 |
| Dragon Pain Relieving Balm | CAMPHOR, MENTHOL | Americanna Wellness, Inc. | 154d8821-3e76-b0e2-e063-6294a90ae077 | 2025-11-12 | Warnings | M017 |
| Good neighbor Pharmacy Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | AMERISOURCEBERGEN DRUG CORPORATION | 87395273-380c-7cef-e053-2991aa0a54c6 | 2025-11-12 | Warnings | M017 |
| Quality Choice Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Chain Drug Marketing Association | 8735b298-83f3-0b5d-e053-2a91aa0a8292 | 2025-11-12 | Warnings | M017 |
| Dragon Pain Relieving Balm | CAMPHOR, MENTHOL | Americanna Wellness, Inc. | 1550e794-b3c0-4769-e063-6294a90a8c2d | 2025-11-12 | 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 |