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 |
|---|---|---|---|---|---|---|
| Pain Relieving | MENTHOL, CAMPHOR, CAPSAICIN | AHC VENTURES CORP DBA CRY | 27679d31-a5f3-417b-b0c5-5f6b001ecff9 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | 52fff03e-eba2-4604-a71c-2522468f627b | 2025-09-02 | Warnings | M017 |
| Pain Relieving Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | de210c3a-c24e-cefd-e053-2a95a90a93ff | 2025-09-02 | Warnings | M017 |
| Pain Relieving Roll-On | MENTHOL, CAMPHOR, CAPSAICIN | AHC VENTURES CORP DBA CRY | 799751f3-726a-42de-934e-dbc3cd1cb8b8 | 2025-09-02 | Warnings | M017 |
| Pain Relieving Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | de0c9a73-dbc0-599e-e053-2a95a90a7986 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | 90334420-5f81-4284-9a57-42e134ce362f | 2025-09-02 | Warnings | M017 |
| KNEE PAIN RELIRF Patch | CAMPHOR, MENTHOL | Shenzhen Finona Information Technology Co., Ltd | 3db971ef-d7fa-0171-e063-6294a90aa58b | 2025-09-01 | Warnings | M017 |
| Bikini Zone Medicated Creme | LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 300ac57e-844a-4840-b285-41ff5518e6b6 | 2025-08-29 | Warnings | M017 |
| Bikini Zone Medicated Gel | LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 30b85890-e72d-4af7-bda9-e7744abc92af | 2025-08-29 | Warnings | M017 |
| Sumifun Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 3d7dc8cc-0680-d94d-e063-6394a90ac8e8 | 2025-08-29 | Warnings | M017 |
| TKTALKER NUMBING | NUMBING | Shenzhen Shandian Jingling Technology Co., Ltd. | 3d7e6757-f183-2a68-e063-6294a90ae4ca | 2025-08-29 | Warnings | M017 |
| PBZ OTC | TRIPELENNAMINE HCL 1% | Kingsway Pharmaceuticals dba NFI, LLC | 12f72d74-018f-4bc6-acd4-175ca3af4c6d | 2025-08-29 | Warnings | M017 |
| else. | LIDOCAINE | Else Co. | 3d6c7b10-ed03-bbde-e063-6294a90ae92f | 2025-08-28 | Warnings | M017 |
| Mountain Ice Pain Relief | MENTHOL | Mountainside Medical Equipment, Inc. | c79fdd91-16f4-4ae0-bee4-d37c05ed2074 | 2025-08-28 | Warnings | M017 |
| HealthWise 4% Lidocaine Cream 2.7 oz | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | f39eb3d0-e153-4f50-85b1-ad5c677d176c | 2025-08-28 | Warnings | M017 |
| HealthWise Overnight Menthol Patch | MENTHOL | Veridian Healthcare | 6379f50d-2878-46ca-8acb-71c4554585e9 | 2025-08-28 | Warnings | M017 |
| Capsaicin | CAPSAICIN | PHARMACURE LLC | 119bab58-f129-4ff0-8d81-9c6a7b508dd6 | 2025-08-28 | Warnings | M017 |
| Anti Itch Maximum Relief | PRAMOXINE HYDROCHLORIDE AND MENTHOL | Natureplex LLC | 75de3d5e-ecbe-4d04-a39d-792200e6ee32 | 2025-08-28 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches | NICOTINE TRANSDERMAL PATCHES | Shenzhen Paxi Trading Co., Ltd. | 3d5718f3-c175-6b64-e063-6394a90aa6f1 | 2025-08-27 | Warnings | M017 |
| ARCTIC HEAT | MENTHOL, METHYL SALICYLATE | Renu Laboratories, LLC | 402df5c1-b8cb-17a2-e054-00144ff8d46c | 2025-08-27 | 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 |