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 |
|---|---|---|---|---|---|---|
| Methyl Salicylate | METHYL SALICYLATE | PHARMACURE LLC | 66b13044-69d2-4559-9e65-8a4c601c077a | 2025-10-06 | Warnings | M017 |
| Methyl Salicylate | METHYL SALICYLATE | PHARMACURE LLC | f119a1bd-095f-41f5-86d5-c0ee4f19fd2c | 2025-10-06 | Warnings | M017 |
| LIDOCAINE | LIDOCAINE | PHARMACURE LLC | 31d5e5c9-6ec4-4496-8a4c-cca39a2cbe32 | 2025-10-06 | Warnings | M017 |
| Tempo cool | MENTHOL | The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E | bd642389-6d03-4e09-a71c-312fb90eae89 | 2025-10-06 | Warnings | M017 |
| Menthopatch Hot | MENTHOL , CAPSICUM EXTRACT | THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID | 3d289be3-c237-4065-a8ac-e8c2e51b76a5 | 2025-10-06 | Warnings | M017 |
| Mentho patch cool | MENTHOL | THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID | 02251a4a-fc6f-42c9-a244-6f4835de5edd | 2025-10-06 | Warnings | M017 |
| Feminine Anti-Itch Creme | BENZOCAINE, RESORCINOL | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | aa6cc963-dc60-5222-e053-2995a90acaf6 | 2025-10-06 | Warnings | M017 |
| TheraCare 2% Diphenhydramine Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Veridian Healthcare | 5999b677-63dd-49c6-b5b8-7b3c117ecc5c | 2025-10-06 | Warnings | M017 |
| HealthWise Pain Relief | MENTHOL | Veridian Healthcare | 06be5331-7a1e-4ab3-9f17-2d350bd4b890 | 2025-10-02 | Warnings | M017 |
| equate Burn Relief | LIDOCAINE HYDROCHLORIDE | Walmart Inc | a90cbd92-80a5-4463-8152-b83165121a6f | 2025-10-02 | Warnings | M017 |
| AsperFlex HOT | CAMPHOR, MENTHOL, METHYL SALICYLATE | Akron Pharma Inc. | a6cb0656-8866-44ff-b40c-73655ff68721 | 2025-10-02 | Warnings | M017 |
| AsperFlex Original Maximum Strength | MENTHOL | Akron Pharma Inc. | d766c61e-c48b-4aff-97b0-678159479e03 | 2025-10-02 | Warnings | M017 |
| HealthWise Feminine Anti-Itch Cream | BENZOCAINE, RESORCINOL | Veridian Healthcare | 1f9110da-f448-8e20-e063-6294a90a4275 | 2025-10-02 | Warnings | M017 |
| PROSTAT FIRST AID Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | dc704403-e2aa-47f7-a7f4-f6afe1547ca8 | 2025-10-01 | Warnings | M017 |
| PROSTAT FIRST AID Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | e02558a9-fe2b-4f28-9fd3-7308f859d759 | 2025-10-01 | Warnings | M017 |
| FL Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | 4dc0d579-ab42-4ea5-9788-5e54d7d318a3 | 2025-10-01 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | c7a7626c-cf82-4301-af79-c5e85367e777 | 2025-10-01 | Warnings | M017 |
| Viaderma Calm Anti-Itch | HYDROCORTISONE | ViaDerma Distribution, Inc. | 7afa2ccd-bfc6-48fc-9a14-a0c6d645844e | 2025-10-01 | Warnings | M017 |
| AsperFlex Advance | CAMPHOR, MENTHOL, METHYL SALICYLATE | Akron Pharma Inc. | d23d7f2b-4dcd-4c31-9d12-340f233018b4 | 2025-10-01 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | SUNSET NOVELTIES, INC | 4024d604-c8c7-2d73-e063-6294a90a2e80 | 2025-10-01 | 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 |