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 |
|---|---|---|---|---|---|---|
| Numbsure LIDOCAINE | LIDOCAINE 4% | Hambli Limited | 43a65a12-ef2a-4608-e063-6394a90a82ea | 2026-01-31 | Warnings | M017 |
| Collajoint Lidocaine Pain Relief Gel Patch | LIDOCAINE PAIN RELIEF GEL PATCH | Henan Enokon Medical Instrument Co., Ltd. | 44e27e7f-992f-d194-e063-6294a90a94e4 | 2026-01-31 | Warnings | M017 |
| CAPSAICIN HEAT Patch | CAPSAICIN HEAT PATCH | Henan Enokon Medical Instrument Co., Ltd. | 49ac2045-2c07-af9a-e063-6294a90a052a | 2026-01-31 | Warnings | M017 |
| COLD AND HOT MEDICATED Patch | COLD AND HOT MEDICATED PATCH | Henan Enokon Medical Instrument Co., Ltd. | 49ac6a7b-25d3-6dc4-e063-6394a90a99b6 | 2026-01-31 | Warnings | M017 |
| COLD AND HOT MEDICATED Patch | COLD AND HOT MEDICATED PATCH | Henan Enokon Medical Instrument Co., Ltd. | 49aca763-be2a-cf38-e063-6294a90a092e | 2026-01-31 | Warnings | M017 |
| PAIN RELIEF HOT Patch | PAIN RELIEF HOT PATCH | Henan Enokon Medical Instrument Co., Ltd. | 49ad128a-0f4c-085a-e063-6294a90ac9bb | 2026-01-31 | Warnings | M017 |
| Walgreens Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 3557d2e9-714a-4066-aa73-ea9e3363e574 | 2026-01-30 | Warnings | M017 |
| Alveora HEMORRHOID MASTER | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER | Jiangxi Yudexi Pharmaceutical Co., LTD | 4996f96a-898e-de01-e063-6394a90a3907 | 2026-01-30 | Warnings | M017 |
| Sunburn Relief | LIDOCAINE HCL 0.5% | Rite Aid Corporation | b67af0c7-1ae8-4494-bb0e-d7f66ebca352 | 2026-01-30 | Warnings, Adverse reactions | M017 |
| Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITIS | CAPSAICIN | OL PHARMA TECH,LLC | 48fdf9dc-05df-866d-e063-6294a90ae03a | 2026-01-30 | Warnings | M017 |
| ROCKTAPE GO Kinesiology Tape and Analgesic | MENTHOL, METHYL SALICYLATE | Implus Footcare, LLC | b779c7d8-dbe6-472f-9282-6cced25cfd2e | 2026-01-29 | Warnings | M017 |
| RockSauce Warming Massage | MENTHOL, METHYL SALICYLATE | Implus Footcare, LLC | de5f7add-1f2b-438a-ac17-753ebb53e697 | 2026-01-29 | Warnings | M017 |
| RockSauce Warming Massage Roll-On | MENTHOL, METHYL SALICYLATE | Implus Footcare, LLC | 5a2d9c3a-67fc-4c1a-b1e8-62a93880397a | 2026-01-29 | Warnings | M017 |
| Analgesic Dr. Collado | MENTHOL, METHYL SALICYLATE | Laboratorios Dr. Collado, S.A | c0dad2db-7c96-49b8-a451-bf8cfa7f798b | 2026-01-29 | Warnings | M017 |
| RockSauce Warming Massage | MENTHOL, METHYL SALICYLATE | Implus Footcare, LLC | 3121c7f7-d7e5-4ca9-9057-03edf9c94c56 | 2026-01-29 | Warnings | M017 |
| Analgesic Gel Dr. Collado Menthol 4 Methyl Salicylate | MENTHOL, METHYL SALICYLATE | Laboratorios Dr. Collado, S.A. | 87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d | 2026-01-29 | Warnings | M017 |
| ProCure Hydrocortisone Cream Plus | HYDROCORTISONE | Rooftop Consumer Health, Inc. | fe334cae-e019-4397-8498-df3c923ae8b5 | 2026-01-29 | Warnings | M017 |
| Red Oil Pain Relief | CAMPHOR (SYNTHETIC), MENTHOL, PHENOL | The Red Oil Company Inc | 1e36579a-72da-46ba-ac72-5960a11c0880 | 2026-01-29 | Warnings | M017 |
| Extra Strength Balm | CAPSICUM, MENTHOL | NATURES FORMULAE HEALTH PRODUCTS LTD. | 498a5e2a-4de0-561c-e063-6394a90ac05c | 2026-01-29 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET POTENT PAIN RELIEF | 45c76956-db3f-3e84-e063-6394a90adce1 | 2026-01-29 | 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 |