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 |
|---|---|---|---|---|---|---|
| Healing Hand Cream 2000mg | MENTHOL | Carolina Cannabis Creations LLC | 01f8795b-9f95-c793-e063-6394a90a8330 | 2025-01-15 | Warnings | M017 |
| CBD Clinic Deep-Rub Pain Relief - Level 5 | CAMPHOR, MENTHOL | ABACUS HEALTH PRODUCTS, INC. | 31e2e5cd-d33e-f058-e063-6394a90af7d2 | 2025-01-14 | Warnings | M017 |
| Meijer Odor Free Analgesic Pain Relieving Topical Analgesic | LIDOCAINE HYDROCHLORIDE | Meijer Distribution, Inc | 6288efea-f636-4eea-bb9f-78aa2f9af54a | 2025-01-14 | Warnings | M017 |
| IKONIK TONIK | LIDOCAINE HYDROCHLORIDE | IKONIK CARE, LLC | 122fdfe8-b5fa-46d1-9fd9-3df9887ed320 | 2025-01-14 | Warnings | M017 |
| elp essential MANTECA DE UBRE | METHYL SALICYLATE, CAMPHOR | Miramar Cosmetics, Inc DBA Miramar Lab | c3964dfe-17fe-4d89-a4c4-cf500f982259 | 2025-01-13 | Warnings | M017 |
| Methylten | METHYL SALICYLATE 10% | Puretek Corporation | 28f4093f-803f-0e70-e063-6294a90a98a4 | 2025-01-13 | Warnings | M017 |
| Refill Bundle 7 Large Office | BENZALKONIUM CHLORIDE | CMC Group, Inc. | 6620a8f3-098d-d045-e053-2a91aa0a0d94 | 2025-01-13 | Warnings | M017 |
| Jakwork Numbing Cream | NUMBING CREAM | Guangzhou Zanming Trading Co., Ltd. | 2ba1de83-494a-6c54-e063-6294a90a9b2d | 2025-01-13 | Warnings | M017 |
| Arthritis Hot | MENTHOL AND METHYL SALICYLATE | Chattem, Inc. | cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd | 2025-01-13 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 00b40dda-53ad-0458-e063-6394a90aa835 | 2025-01-11 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 00b47eb7-6b43-d9e2-e063-6294a90a9a38 | 2025-01-11 | Warnings | M017 |
| Re-Lieved 4% Lidocaine Fabric Tape | LIDOCAINE 4% FABRIC TAPE | Transfer Technology | e9a894b0-54f2-707e-e053-2a95a90a0f0d | 2025-01-11 | Warnings | M017 |
| Re-Lieved 3 in 1 Patch | MENTHOL, CAMPHOR, METHYL SALICYLATE PATCH | Transfer Technology | e9ab9a03-b9e3-7317-e053-2995a90a9950 | 2025-01-11 | Warnings | M017 |
| ASTRAPHARM CHILLI BRAND | CAPSAICIN | Dersan Pharmaceutical Co., Ltd | b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec | 2025-01-10 | Warnings | M017 |
| LABOFLEX Lidocaine Pain Relieving Patch | LIDOCAINE 4% | Laboflex, Inc. | 31995f31-c272-afdb-e063-6294a90af3f9 | 2025-01-10 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Chain Drug Marketing Association Inc. | 2b48cb2f-e6bf-f9de-e063-6394a90a42d4 | 2025-01-09 | Warnings | M017 |
| PAIN-X | MENTHOL | OL PHARMA TECH,LLC | b22bb19a-14e5-3d32-e053-2a95a90ae520 | 2025-01-09 | Warnings | M017 |
| MUSCLE RUB | MENTHOL | OL PHARMA TECH,LLC | b22c7999-52d5-25c3-e053-2a95a90a01f5 | 2025-01-09 | Warnings | M017 |
| Biofreeze Professional Colorless Roll-On | MENTHOL, UNSPECIFIED FORM | A-S Medication Solutions | ce392c4f-cc43-484d-9c49-18fa25e4e5e9 | 2025-01-09 | Warnings | M017 |
| NEW TEROCIN | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | A-S Medication Solutions | 43e5eb27-5541-4b7b-80de-55a79a4dce55 | 2025-01-09 | 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 |