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 |
|---|---|---|---|---|---|---|
| Lidocaine 4% Topical Anesthetic Cream | LIDOCAINE 4% | Oncor Pharmaceuticals | 1baaa669-05af-4024-a0ba-ee3451756f6a | 2026-01-05 | Warnings | M017 |
| TheraCare Pain Relief | MENTHOL | Veridian Healthcare | 6834a6de-4d1d-4e40-945d-ec5c267abd14 | 2026-01-05 | Warnings | M017 |
| TheraCare Lidocaine Pain Relief | LIDOCAINE | Veridian Healthcare | ee8cd550-64ee-432e-98e5-b68083179a3c | 2026-01-05 | Warnings | M017 |
| REGENECARE HA | LIDOCAINE HCL | MPM Medical LLC | 0eee554f-dfe0-433a-9665-8bdb95229888 | 2026-01-05 | Warnings | M017 |
| Pain Relieving Cream | CAMPHOR AND MENTHOL | PAIN WIZARD LIMITED LIABILITY COMPANY | 2647bba1-87f4-3c16-e063-6394a90ae0c9 | 2026-01-05 | Warnings | M017 |
| TheraCare Lidocaine plus Menthol | LIDOCAINE, MENTHOL | Veridian Healthcare | efddd116-d753-425a-9ded-09b8045024e4 | 2026-01-05 | Warnings | M017 |
| TheraCare Original Menthol | MENTHOL | Veridian Healthcare | ea56e4e1-a758-428b-8758-ee31bb00ca82 | 2026-01-05 | Warnings | M017 |
| Mugwort Patch (Cervical spine use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e220c-0d35-9ee0-e063-6294a90ab689 | 2026-01-04 | Warnings | M017 |
| Mugwort Patch (Lumbar spine use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e4b21-6d81-4cd3-e063-6394a90a18fe | 2026-01-04 | Warnings | M017 |
| Mugwort Patch (Knee use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e86d2-3030-91eb-e063-6394a90a4db0 | 2026-01-04 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | 4a543f90-d43c-4487-b27e-f43394c6320d | 2026-01-04 | Warnings | M017 |
| Doctor Hoys Pain Relief Gel | MENTHOL, CAMPHOR (SYNTHETIC) | Dynamic Blending Specialists, Inc. | 50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a8 | 2026-01-02 | Warnings | M017 |
| Doctor Hoys Pain Relief Gel Roll-On | MENTHOL, CAMPHOR (SYNTHETIC) | Dynamic Blending Specialists, Inc. | bf47acb2-6c90-4d5c-820b-447cac9305a4 | 2026-01-02 | Warnings | M017 |
| Amino Rip Muscle Pain Relief | LIDOCAINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 2bed5764-4217-4aa3-9d90-3b5460dcffa3 | 2026-01-02 | Warnings | M017 |
| Menthozen Cream | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Village Pharma LLC | 63bb0283-cfbe-4e9c-8772-73062c0c8d05 | 2026-01-01 | Warnings | M017 |
| Menthozen Hydrogel | MENTHOL, CAPSAICIN | Village Pharma LLC | 4c979a71-7c8f-4dff-abae-bf4cdf8f67b4 | 2026-01-01 | Warnings | M017 |
| Lidozen Gel | LIDOCAINE HYDROCHLORIDE, MENTHOL | Village Pharma LLC | ffb7831f-4ca9-4d73-8303-e9cd90078982 | 2026-01-01 | Warnings | M017 |
| Sting Relief | BENZOCAINE, ISOPROPYL ALCOHOL | Yiwu Ori-Power Medtech Co.,Ltd. | 116ee6dc-9c49-2e11-e063-6394a90a44ed | 2026-01-01 | Warnings | M017 |
| Menthozen | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Village Pharma LLC | 48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb13 | 2026-01-01 | Warnings | M017 |
| NUVALU ICE THERAPY MENTHOL PAIN RELIEVING | MENTHOL | JC SALES | 5adf457e-b4d0-30c8-e063-6294a90a64b9 | 2026-01-01 | 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 |