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 |
|---|---|---|---|---|---|---|
| SunBurnt PLUS | LIDOCAINE HYDROCHLORIDE | Quest Products, LLC. | 12128c75-015d-8a72-e063-6394a90ae00a | 2024-02-23 | Warnings | M017 |
| Kroger Analgesic Analgesic | LIDOCAINE HYDROCHLORIDE | THE KROGER CO | e6c5ead3-87d0-48ed-a4dc-86cf89ebb285 | 2024-02-22 | Warnings | M017 |
| Rugby Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Bryant Ranch Prepack | fcf48536-224e-4a3d-9124-770031823972 | 2024-02-22 | Warnings | M017 |
| meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic | MENTHOL, UNSPECIFIED FORM | Meijer Distribution, Inc | 8bc3956b-b82d-4ed3-8bc3-db0078466bbc | 2024-02-22 | Warnings | M017 |
| Promescent Delay Wipes | BENZOCAINE | Absorption | f0a5b6be-acc5-473c-9054-b9534e769db1 | 2024-02-20 | Warnings | M017 |
| Ralli Rapid Pain Relief | MENTHOL | Troy Manufacturing, Inc. | 721658dc-3b1d-43ff-9032-e96851633cf9 | 2024-02-19 | Warnings | M017 |
| Ralli Rapid Pain Relief Roll on | MENTHOL | Troy Manufacturing, Inc. | 978d5c2c-fdc4-4d25-83ec-0b9404ec8018 | 2024-02-19 | Warnings | M017 |
| 1168 | 1168 BURN SPRAY | Dynarex Corporation | 1183a4f5-f875-dfb0-e063-6394a90af35f | 2024-02-16 | Warnings | M017 |
| Pain Relief | BENZOCAINE | Safetec of America, Inc. | de84e598-d047-4fae-b2ed-155a3788bc6f | 2024-02-16 | Warnings | M017 |
| No Mess Hydrocortisone Applicator | HYDROCORTISONE | Walgreen Co. | cfefb517-9099-41c4-8a95-74414ca4032c | 2024-02-16 | Warnings | M017 |
| Analgesic Balm | MENTHOL 10%, METHYL SALICYLATE 15% | Geri-Care Pharmaceuticals, Corp | ab9bf09d-bc8c-6d17-e053-2995a90a6c36 | 2024-02-14 | Warnings | M017 |
| Natures Oil 16% Menthol | MENTHOL, UNSPECIFIED FORM | NATURAL ESSENTIALS, INC. | 2fbe23b7-23a3-4f0b-bc08-0205256f5d68 | 2024-02-14 | Warnings | M017 |
| Rugby Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Rugby Laboratories | 4c11876c-57ec-4429-a8c4-fb95baa4074a | 2024-02-13 | Warnings | M017 |
| Itch stopping Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Trifecta Pharmaceuticals USA, LLC. | 11368823-d4af-a536-e063-6294a90a7a2e | 2024-02-12 | Warnings | M017 |
| Walgreens Boil Pain Relief | BOIL PAIN RELIEF | Walgreens Company | d11bd769-68d0-4057-bc2a-72719f16011e | 2024-02-12 | Warnings | M017 |
| Capsaicin | CAPSAICIN | Rugby Laboratories | c5915c84-84a2-46f6-9f97-0d9873e9944a | 2024-02-12 | Warnings | M017 |
| Leader Ice Blue Analgesic | MENTHOL, UNSPECIFIED FORM | Cardinal Health, 110 dba LEADER | 952e56ea-5cbc-4078-bd01-5d3b6864a5ce | 2024-02-09 | Warnings | M017 |
| Leader Ultra Strength Muscle Rub Topical Analgesic | CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE | Cardinal Health, 110 dba LEADER | 9d99a900-60e0-454c-98e0-2c63eb910cf1 | 2024-02-09 | Warnings | M017 |
| Pain Relieving | CAMPHOR (NATURAL) | J.R. Watkins, LLC. | 28821ffa-a138-47b5-8857-beadf7a20d43 | 2024-02-08 | Warnings | M017 |
| Menthol Camphor Cough Suppressant Topical Analgesic Rub | CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | fd0ea70a-ef12-48b1-8d9d-cc5f6417f854 | 2024-02-08 | 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 |