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 |
|---|---|---|---|---|---|---|
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cfde0-c463-e9b5-e053-2a95a90a1924 | 2024-01-15 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cce4b-c70a-1b2d-e053-2995a90aa4aa | 2024-01-15 | Warnings | M017 |
| Oral Pain Relief Gel | BENZOCAINE 20% | Sled Distribution, LLC | e7391302-831e-14dc-e053-2a95a90ac236 | 2024-01-15 | Warnings | M017 |
| FIRST SHIELD | LIDOCAINE HCI | Ever Ready First Aid | e022bf8f-3dd8-de22-e053-2995a90a219b | 2024-01-15 | Warnings | M017 |
| Flexigen | MENTHOL 1.25% | Derma Care Research Labs, LLC | e9ae2682-59b4-e796-e053-2995a90af921 | 2024-01-15 | Warnings | M017 |
| Vita-P Oral and Nasal | MENTHOL 1% | Beijing HKKY Medical Tech. Co., Ltd. | 537c3843-1c92-41c6-b724-52701bbddeab | 2024-01-13 | Warnings | M017 |
| Caring mill Lidocaine Aloe Gel Burn and Pain Relief | LIDOCAINE HYDROCHLORIDE | FSA Store Inc. | 0ec20c87-1681-dd23-e063-6394a90a291c | 2024-01-12 | Warnings | M017 |
| Cool n Heat | COOL N HEAT | NeilMed Pharmaceuticals, Inc. | a24cde17-280b-8358-e053-2a95a90af67d | 2024-01-11 | Warnings | M017 |
| NeilMed Anti-Itch | ANTI-ITCH SPRAY | NeilMed Pharmaceuticals Inc. | b3d34d9e-85d9-df4e-e053-2a95a90ac8d9 | 2024-01-11 | Warnings | M017 |
| NeilMed Hot and Cold Pain Relief | PAIN RELIEF SPRAY | NeilMed Pharmaceuticals Inc. | b3d02111-7499-c2d4-e053-2a95a90ae1de | 2024-01-11 | Warnings | M017 |
| Cooling Itch Relief | COOLING ITCH RELIEF | NeilMed Pharmaceuticals, Inc | a24bdea0-18e8-8a5e-e053-2995a90acea2 | 2024-01-11 | Warnings | M017 |
| Lightning X Burn | LIDOCAINE | Nantong Health & Beyond Hygienic Products Inc. | 0e69a971-0c6e-6ebe-e063-6394a90a0b33 | 2024-01-08 | Warnings | M017 |
| Theraworx Pain Relief Roll-On with Lidocaine for Diabetics | LIDOCAINE HYDROCHLORIDE | AVADIM HOLDINGS, INC. | e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29 | 2024-01-08 | Warnings | M017 |
| 2nd CHANCE MOBILITY Pain Relief | HISTAMINE DIHYDROCHLORIDE | ALPHA NUTRITION, LLC | 575097ac-9fc9-4391-99d1-dff9b34817e3 | 2024-01-08 | Warnings | M017 |
| Tiger Balm Arthritis Rub | CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM | Haw Par Healthcare Ltd. | 80932288-4797-40d3-aa8a-6af686fb67ad | 2024-01-08 | Warnings | M017 |
| OPRAVA | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Biological M.D. Solutions LLC | 05552560-e283-5eba-e063-6294a90a65f7 | 2024-01-06 | Warnings | M017 |
| MED O-3 BIO- | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Biological M.D. Solutions LLC | 02707552-03d9-3ad2-e063-6294a90a3472 | 2024-01-06 | Warnings | M017 |
| Sumifun Knee Relieving Patch | KNEE RELIEVING PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0e7e73ec-ab33-9235-e063-6394a90ad950 | 2024-01-06 | Warnings | M017 |
| Lidocaine Numbing Cream | LIDOCAINE | YYBA Corp | de6dc194-c6ef-4cb5-be3f-e772ace9abaf | 2024-01-03 | Warnings | M017 |
| Equate Vagicaine | 20% BENZOCAINE AND 3% RESORCINOL CREAM | Walmart Inc. | 0cdc9323-f5c3-468c-a7ae-83dfd2d76626 | 2024-01-03 | 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 |