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 |
|---|---|---|---|---|---|---|
| Genuine First Aid Alcohol Cleansing Pad | BENZOCAINE, ALCOHOL | GFA Production (Xiamen) Co., Ltd. | c39c4d80-9718-459f-8ae4-ada043bba5b7 | 2024-06-26 | Warnings | M017 |
| Eagle Brand Medicated Roll On | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 1bd5cf69-9a08-5e2e-e063-6394a90a03cd | 2024-06-26 | Warnings | M017 |
| Solarcaine Burn Pain Relief 4oz | SOLARCAINE BURN PAIN RELIEF 4OZ | WellSpring Pharmaceutical Corporation | 2c0389db-ceb2-422b-9575-bdb8fe649a1e | 2024-06-26 | Warnings | M017 |
| astonea | HYDROCORTISONE | ASTONEA LABS PRIVATE LIMITED | de09e859-c5fd-0cc5-e053-2a95a90a147e | 2024-06-25 | Warnings | M017 |
| HealthWise Pain Relief Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 0190196d-5f78-042b-e063-6294a90a3714 | 2024-06-25 | Warnings | M017 |
| Eagle Brand Medicated Oil | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 1bc1bf83-91ee-ec9d-e063-6394a90a3daf | 2024-06-25 | Warnings | M017 |
| Eagle Brand Medicated Roll On | MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 1bc2f688-d0c4-690e-e063-6294a90abc38 | 2024-06-25 | Warnings | M017 |
| Eagle Brand Medicated Oil | MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 1b9fdac0-9fb0-e669-e063-6394a90aece9 | 2024-06-24 | Warnings | M017 |
| Capsaicin | CAPSAICIN | Asclemed USA, Inc. | 97d506bd-3215-4e2e-9914-af1c174dd4ab | 2024-06-20 | Warnings | M017 |
| ABREVA Rapid Pain Relief | GLYCERIN, LIDOCAINE | Haleon US Holdings LLC | 65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d | 2024-06-20 | Warnings | M017 |
| Frankie Avalons ZERO PAIN Roll-On Pain Reliever | CAPSAICIN | WHY ENTERPRISES LLC | e32acb5f-5bc3-4228-b037-6315d080f556 | 2024-06-17 | Warnings | M017 |
| PUREGEN LABS Pain Relief 4 Lidocaine | LIDOCAINE | Advanced Rx LLC | 9dff40d8-8d7e-4629-bea5-987f5e68477d | 2024-06-11 | Warnings | M017 |
| SMOOTH GATOR Head-Ezz Analgesic | MENTHOL | Smooth Gator LLC | 02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd | 2024-06-10 | Warnings | M017 |
| FIRST AID BURN | LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE | Epic Medical Supply Corp | bd1b1873-e900-45eb-96a0-28f782b5a7cd | 2024-06-04 | Warnings | M017 |
| Hydrocortisone 1% | HYDROCORTISONE | Chain Drug Marketing Association Inc. | 1c834ba0-86b6-8e61-e063-6394a90a192d | 2024-06-04 | Warnings | M017 |
| HealthWise Feminine Anti-itch Cream | BENZOCAINE, RESORCINOL | Veridian Healthcare | 19fe7c3b-58e2-6c16-e063-6394a90a612a | 2024-06-03 | Warnings | M017 |
| THE SOLUTION NUMBING | LIDOCAINE HYDROCHLORIDE | SCALP TECH INC | 184be4cc-b0b9-7882-e063-6394a90a8e7e | 2024-05-25 | Warnings | M017 |
| Methyl Salicylate 25 Percent | METHYL SALICYLATE | Alexso, Inc | d8b8b0ba-69e9-4965-bf9b-6db21db69b34 | 2024-05-23 | Warnings | M017 |
| Meijer Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Meijer Distribution | 07ecc6a7-bbe3-35cf-e063-6394a90a2180 | 2024-05-22 | Warnings | M017 |
| TheraCare Hydrocortisone Cream | HYDROCORTISONE | Veridian Healthcare | 01cb7b47-2c3c-707d-e063-6294a90a5d97 | 2024-05-21 | 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 |