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 |
|---|---|---|---|---|---|---|
| JenGufun LIDOCAINE KNEE Patch | LIDOCAINE KNEE PATCH | Henan Kangdi Medical Devices Co., Ltd. | 5b1d8508-b993-7a8d-e063-6294a90ae306 | 2026-09-10 | Warnings | M017 |
| Wart Corn Remover | SALICYLIC ACID | HONG KONG FOREVER YOUNG TRADING CO., LIMITED | 5b0cd6e0-f220-4ebd-e063-6294a90ade67 | 2026-09-09 | Warnings | M017 |
| Magic Cream | PAIN RELIEVING OINTMENT | Jiangxi Baikang Medical Products Co., Ltd. | 5b0f2515-47e9-603f-e063-6294a90af9d4 | 2026-09-09 | Warnings | M017 |
| Burn Gel | LIDOCAINE HCI | Trifecta Pharmaceuticals USA LLC | e9d3e9be-1036-fad0-e053-2a95a90a6efe | 2026-09-09 | Warnings | M017 |
| 4% Lidocaine Pain Relief Patch | LIDOCAINE 4% | Guangxi Keyun E-commerce Co., Ltd. | 5b197cd8-542f-38b4-e063-6294a90ad7d3 | 2026-09-09 | Warnings | M017 |
| Pain Relieving Lidocaine Patch | LIDOCAINE | YYBA CORP | af8c84fd-224c-72b3-e053-2a95a90a9568 | 2026-09-07 | Warnings | M017 |
| American Safety First Aid | LIDOCAINE HCL | Orazen Inc | ea2f776b-dfd0-6ce4-e053-2995a90af009 | 2026-09-07 | Warnings | M017 |
| MEDI-FIRST Topical Analgesic | LIDOCAINE HCI | Ultra Distributors Inc | b6f288f7-9ae3-215e-e053-2a95a90aedf6 | 2026-09-07 | Warnings | M017 |
| MEDI-FIRST | BENZALKONIUM CHLORIDE, LIDOCAINE | Orazen Inc | f508434f-5948-7134-e053-2a95a90a03d7 | 2026-09-05 | Warnings | M017 |
| MEDI-FIRST | BENZALKONIUM CHLORIDE, LIDOCAINE | Orazen Inc | f522fb0b-3d86-b228-e053-2a95a90a55e9 | 2026-09-05 | Warnings | M017 |
| SurviveX Anti-itch Cream | SURVIVEX HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | 5a7a1141-d3b1-0ee8-e063-6294a90a16aa | 2026-09-04 | Warnings | M017 |
| NeuroNesic Pain Relieving Cream | CAPSAICIN | Blaine Labs Inc. | 7107c13d-bf59-4c0a-84fe-725a9fca2691 | 2026-09-04 | Warnings | M017 |
| Neoteric Diabetic Skin Care 1 oz. | DIMETHICONE | RNA PHARMA LLC | 5a944486-9591-f583-e063-6394a90aa04b | 2026-09-03 | Warnings | M017 |
| Equate Menthol Pain Relieving | MENTHOL | Wal-Mart Stores Inc | d5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc | 2026-09-03 | Warnings | M017 |
| ZHI Technologies | LIDOCAINE, MENTHOL | ZHI Technologies, Inc. | 6717e995-4d2d-49e8-8ecf-7c62557dfdef | 2026-09-03 | Warnings | M017 |
| Komxsum LIDOCAINE Cream | LIDOCAINE 4% CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5a9feae0-9be4-e736-e063-6294a90abe55 | 2026-09-03 | Warnings | M017 |
| FREEZE EASE Roll-On | MENTHOL | Global America Group LLC | 1869cc0d-a056-45de-aede-23b09b61ed12 | 2026-09-02 | Warnings | M017 |
| Gaimoa Lidocaine Pain Relief Gel Patches | LIDOCAINE PAIN RELIEF GEL PATCHES | Henan Enokon Medical Instrument Co., Ltd. | 5a68fe67-5c15-af9a-e063-6294a90a7ec1 | 2026-09-01 | Warnings | M017 |
| CVS Cortisone Liquid | HYDROCORTISONE | CVS Pharmacy | 42df45a9-d449-090a-e063-6394a90a9ee4 | 2026-09-01 | Warnings | M017 |
| Ramedica Herbal Wonder Balm | CAMPHOR, MENTHOL | Ramedicare Sdn. Bhd. | cfb2ea0e-a1f6-4fdf-b866-346bbe78788f | 2026-09-01 | 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 |