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 |
|---|---|---|---|---|---|---|
| HealthWise Ultra OTC Strength Pain Relief Cream | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | Veridian Healthcare | 36c3bbf9-a559-4c0d-e063-6394a90a8a1a | 2025-06-04 | Warnings | M017 |
| Everlight Survival Sting Relief Pad | BENZOCAINE | Yiwu Ori-Power Medtech Co.,Ltd. | 364c9882-339e-fe22-e063-6294a90a37f4 | 2025-06-04 | Warnings | M017 |
| LIGHTS Sting Relief Prep Pad | BENZOCAINE | Lights Medical Manufacture Co., Ltd. | 4f4d7758-be62-4304-8871-087a90497fa5 | 2025-06-04 | Warnings | M017 |
| Elsophie Nicotine Patches Quit | NICOTINE PATCHES QUIT SMOKING | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 36b63da9-94cc-b52a-e063-6394a90a5029 | 2025-06-03 | Warnings | M017 |
| Burn | LIDOCAINE HYDROCHLORIDE | J&A Digital Inc. | d4b09055-b93e-466f-9e24-cae098af6e24 | 2025-06-02 | Warnings | M017 |
| RE-LEVE | MENTHOL | SOMBRA COSMETICS INC. | b4b39d79-0439-41e7-adca-e5ccb8f44e40 | 2025-05-29 | Warnings | M017 |
| PAIN NO MORE THERAPY | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | f7bacc8e-6a8b-4cd8-bd0e-68890bee5818 | 2025-05-29 | Warnings | M017 |
| DermaD ANTI-ITCH Therapeutic | SALICYLIC ACID | Chen Cohen Industries Inc. | 8f4a57cb-0a5b-42b0-a325-1f92f3942ad9 | 2025-05-29 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | f7aecfb4-c194-4554-8d05-4e46005e654b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | b679ed7b-9d88-4eff-9743-567affe0fe2b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage Roll On | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | 28eb8273-5789-4f33-bbbe-3a5ec7bc7929 | 2025-05-27 | Warnings | M017 |
| AUVON Pain Relief Cream | LIDOCAINE | SHENZHEN YUWEN E-COMMERCE CO., LTD. | 358c2632-3b90-1c54-e063-6294a90ad461 | 2025-05-22 | Warnings | M017 |
| WelAhead by Welmate Lidocaine 5% Roll-on | LIDOCAINE 5% | OTC PHARM LLC | 0b75e83e-8c7b-6247-e063-6294a90ac413 | 2025-05-21 | Warnings | M017 |
| Bliss Republic | LIDOCAINE NUMBING EXTRA STRENGTH CREAM | Sargass Group Limited Liability Company | 35aba13a-95e6-a395-e063-6294a90a5bdc | 2025-05-21 | Warnings | M017 |
| Xpect Stopain Clinical | MENTHOL | Cintas Corporation | e911478f-7153-4700-b945-92ec54972f45 | 2025-05-21 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Preferred Pharmaceuticals Inc. | 0976a898-8d79-4b85-b473-c8ad32b4fd00 | 2025-05-20 | Warnings | M017 |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 359884d6-188a-e503-e063-6294a90acab4 | 2025-05-20 | Warnings | M017 |
| AY BENDITO - THERMOACTIVE | CAMPHOR, MENTHOL | AY BENDITO - THERMOACTIVE LOTION | 835abc66-680f-be06-e053-2a91aa0a309e | 2025-05-19 | Warnings | M017 |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 35884644-d017-eda3-e063-6394a90a1f6c | 2025-05-19 | Warnings | M017 |
| QUIT SMOKING Proven Patches | NICOTINE | Jiashen International Trade Limited | 35570155-c769-dc4c-e063-6394a90a019d | 2025-05-17 | 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 |