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 |
|---|---|---|---|---|---|---|
| Claravie | CAMPHOR | Gentell LLC | 5978bdab-5359-be9a-e063-6394a90a5a32 | 2026-08-20 | Warnings | M017 |
| Rugby PAIN RELIEF PATCHES | LIDOCAINE | RUGBY LABORATORIES | b34e40c8-a257-46cf-9399-f55df9b4102d | 2026-08-20 | Warnings | M017 |
| MAXIMUM STRENGTH Lidocaine Plus Menthol | LIDOCAINE, MENTHOL | ARMY AND AIR FORCE EXCHANGE SERVICE | 60f72061-d264-424e-b396-5a609076d352 | 2026-08-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 5980c527-6bcb-a846-e063-6294a90a0788 | 2026-08-20 | Warnings | M017 |
| Pain Relief Patches | CAMPHOR, MENTHOL, METHYL SALICYLATE | Amerisource Bergen | 5fb5e5ce-b268-4444-8b63-ea7ea6abf269 | 2026-08-20 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 58c2b35c-e1ed-7ea8-e063-6294a90a1494 | 2026-08-19 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 585e740b-e4fa-d2aa-e063-6294a90a0982 | 2026-08-19 | Warnings | M017 |
| Eagle Brand Muscular Balm | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 0822bcde-a8ad-be95-e063-6294a90ad208 | 2026-08-19 | Warnings | M017 |
| ANTI ITCH | HYDROCORTISONE | HyVee Inc | 1ab6bbb8-2b91-4c53-9168-b1e85ac296e9 | 2026-08-19 | Warnings | M017 |
| hydrocortisone 1 | HYDROCORTISONE | Kroger Company | f05edff2-2dc5-427c-b52c-518e0aaef4e0 | 2026-08-19 | Warnings | M017 |
| MedPride | HYDROCORTISONE | Shield Line LLC | 2f15d3b3-d1e6-4742-9eac-f956c0ffbba4 | 2026-08-18 | Warnings | M017 |
| Pain Relieving Cream Analgesic | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Garcoa, Inc. | 2f736307-5cd4-4a76-9044-4aeecba096cc | 2026-08-18 | Warnings | M017 |
| Lidocaine Pain Relief Roll on | PAIN RELIEF ROLL ON | NeilMed Pharmaceuticals Inc | 58ff9d2d-99e6-8f98-e063-6394a90a8de7 | 2026-08-17 | Warnings | M017 |
| MENTOL CHINO FORTE | METHYL SALICYLATE, MENTHOL, CAMPHOR | LABORATORIOS H.G. C.A. | 12652c98-e2a8-21fc-e063-6394a90a94cb | 2026-08-17 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1/2% | Sun Pharmaceutical Industries, Inc. | 59337940-c9be-58af-e063-6394a90abe13 | 2026-08-16 | Warnings | M017 |
| SIERQ Numbing | MENTHOL | Putian Licheng District Zhijiancheng Trading Co., Ltd. | 5936c070-d8e4-56e8-e063-6294a90a5600 | 2026-08-16 | Warnings | M017 |
| Jakwork Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5911d9b0-1acb-3546-e063-6294a90adb3a | 2026-08-15 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 59072f05-eefa-d823-e063-6394a90a0e1a | 2026-08-14 | Warnings | M017 |
| JJ Care First Aid Burn | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Nantong Health & Beyond Hygienic Products Inc. | c41621fb-c549-4394-a4cb-cb81ef8c98df | 2026-08-13 | Warnings | M017 |
| JJ Care | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | c88fa151-f8a8-4de2-98c9-71319bf53e36 | 2026-08-13 | 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 |