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 |
|---|---|---|---|---|---|---|
| VBBV Tattoo Numbing | LIDOCAINE | Jiashen International Trade Limited | 3557859e-f8b3-1049-e063-6394a90ad737 | 2025-05-17 | Warnings | M017 |
| Bliss Republic Lidocaine Numbing Cream | LIDOCAINE NUMBING CREAM | Sargass Group Limited Liability Company | 35415851-beba-5bb4-e063-6294a90a35c0 | 2025-05-16 | Warnings | M017 |
| Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 352798e1-1e09-3d47-e063-6394a90ad404 | 2025-05-15 | Warnings | M017 |
| Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 35285d62-c660-a056-e063-6294a90aabc8 | 2025-05-15 | Warnings | M017 |
| SionBiotext Hydrocortisone | HYDROCORTISONE ACETATE 1% | Sion Biotext Medical Ltd | 35073eae-26fe-2bb5-e063-6294a90ab56a | 2025-05-13 | Warnings | M017 |
| Bliss Republic Lidocaine Numbing Cream | LIDOCAINE NUMBING CREAM | Sargass Group Limited Liability Company | 3508ae14-d9c9-3c85-e063-6294a90a0098 | 2025-05-13 | Warnings | M017 |
| SORE NO MORE WARM THERAPY | MENTHOL AND CAMPHOR | SOMBRA COSMETICS INC. | cd86b56e-9b4c-4aca-9740-c8793cb12055 | 2025-05-12 | Warnings | M017 |
| SORE NO MORE COOL THERAPY | MENTHOL | SOMBRA COSMETICS INC. | 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 | 2025-05-12 | Warnings | M017 |
| Calm and Correct Serum with Lidocaine | LIDOCAINE 3 PERCENT | Renu Laboratories, LLC | ddcf1c2e-2f67-44d7-e053-2a95a90a812b | 2025-05-09 | Warnings | M017 |
| Mqupin Knee Patch | KNEE PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 09772e4b-8193-3771-e063-6394a90a9516 | 2025-05-08 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | d57a59fb-c8f2-f73b-e053-2995a90a4cdb | 2025-05-08 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | 4c96ec41-841c-322b-e054-00144ff8d46c | 2025-05-08 | Warnings | M017 |
| GNP Extra Strength Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Amerisource Bergen | 34a66224-ef3c-e36e-e063-6394a90ac99d | 2025-05-08 | Warnings | M017 |
| Good Neighbor Muscle Rub Cream | CAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%, | Amerisource Bergen | 34924bb9-e3e8-70e6-e063-6294a90aaa8c | 2025-05-07 | Warnings | M017 |
| DermaRad Relief Post Radiation Calming | LIDOCAINE 3 PERCENT | Renu Laboratories, LLC | e5d64929-fb9c-7ebc-e053-2995a90a9318 | 2025-05-07 | Warnings | M017 |
| Cold Hot Medicated Patch 5% Menthol | MENTHOL | InterMed Laboratories Private Limited | 33ee0235-5a6e-0ea1-e063-6394a90a89a5 | 2025-05-06 | Warnings | M017 |
| DermaRad Relief | LIDOCAINE EMULSION | RENU LABORATORIES, LLC | d5e11f73-918b-eeac-e053-2995a90a4a83 | 2025-05-06 | Warnings | M017 |
| Plantar Fasciitis Pain Relief Gel-Patch | LIDOCAINE, MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 34838622-b092-afeb-e063-6294a90ae7db | 2025-05-06 | Warnings | M017 |
| Climax Shield Delay | BENZOCAINE | PRODUCT MAX GROUP INC | 9c720cdc-f753-47ce-95ff-3b26e461a0ab | 2025-05-05 | Warnings | M017 |
| PediFix Lidocaine Pain-Relief Patches | LIDOCAINE PAIN-RELIEF PATCHES | PediFix, Inc | 346550b9-d2ba-184e-e063-6394a90a591a | 2025-05-05 | 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 |