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 |
|---|---|---|---|---|---|---|
| 4% Lidocaine Pain Relief Patch | LIDOCAINE 4% | Guangxi Keyun E-commerce Co., Ltd. | 4981e9c3-2a19-aed8-e063-6294a90af216 | 2026-07-17 | Warnings | M017 |
| endurance wipe | BENZOCAINE | Absorption Pharmaceuticals, LLC | 303db1de-94fc-4543-e063-6294a90a01b9 | 2026-07-17 | Warnings | M017 |
| Professional Therapy MuscleCare pain relieving gel Extra Strength | CAMPHOR, MENTHOL | Active and Innovative Inc. | 56d30c33-ef5a-c63d-e063-6294a90acd29 | 2026-07-17 | Warnings | M017 |
| Mineral Ice Extreme Gel Alpine Fresh Scent | MENTHOL | Carlin Consumer Health LLC | 56d3ca3d-21e1-a40a-e063-6294a90a9ff4 | 2026-07-17 | Warnings | M017 |
| LYEON Anti-itch Cream | HYDROCORTISONE | Guangzhou Xinhongda Trading Service Co., Ltd. | 56b773ce-167f-7873-e063-6394a90a9816 | 2026-07-16 | Warnings | M017 |
| DRAVYNOR TOPICAL ANALGESIC HEAT Patch | MENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56b83ee8-8d86-9436-e063-6294a90a0c25 | 2026-07-16 | Warnings | M017 |
| OWELL NATURALS NEUROPATHY MAXIMUM STRENGTH | MENTHOL | OWELL NATURAL 8 LLC | 56b8d0cc-2f35-7d38-e063-6294a90ad06d | 2026-07-16 | Warnings | M017 |
| ANTIPHLAMINE | L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE | Masaem Company | 56b93c89-295b-f33a-e063-6294a90a5fe4 | 2026-07-16 | Warnings | M017 |
| Meriwether Skin Pain Relief | MENTHOL, UNSPECIFIED FORM | Meriwether Skin LLC | f6e155be-5879-4176-bb0e-e364f2e5cdf9 | 2026-07-16 | Warnings | M017 |
| Medi-First Muscle Rub Cream | MENTHOL, METHYL SALICYLATE | Unifirst First Aid Corporation | 56a6b8b2-7ab0-9854-e063-6294a90ab5ba | 2026-07-15 | Warnings | M017 |
| Painsil Pain Relief Roll-On | LIDOCAINE HYDROCHLORIDE | Painsil LLC | dee39dff-5749-4ef2-a9ed-182f25e01f67 | 2026-07-14 | Warnings | M017 |
| VARICOSE VEINS MAXIMUM STRENGTH | MENTHOL | OWELL NATURAL & LLC | 5692914f-1b14-e3e3-e063-6394a90a94bf | 2026-07-14 | Warnings | M017 |
| Barmicil Plus | HYDROCORTISONE | OPMX LLC | 5698207f-9223-f3a6-e063-6294a90a8ab6 | 2026-07-14 | Warnings | M017 |
| ZyloRelief | LIDOCAINE HYDROCHLORIDE | Highmark Pharma LLC | 635f5b98-f74c-495f-a537-686fcba9ccad | 2026-07-14 | Warnings | M017 |
| ENOKON PAIN RELIEF Cream | PAIN RELIEF CREAM | Henan Enokon Medical Instrument Co., Ltd. | 567502df-d5f0-a3f7-e063-6394a90a57f0 | 2026-07-12 | Warnings | M017 |
| ENOKON PAIN RELIEF Spray. | PAIN RELIEF SPRAY. | Henan Enokon Medical Instrument Co., Ltd. | 5675ec21-b947-2206-e063-6294a90aa509 | 2026-07-12 | Warnings | M017 |
| Topcare Pain Relief Patch | PAIN RELIEF PATCH MEDICATED 5% MENTHOL | 76162 | 4f00d0b8-d2f4-843b-e063-6294a90a332b | 2026-07-12 | Warnings | M017 |
| Penetral Roll-on | CAPSAICIN 0.025% | PureTek Corporation | 56204c03-8b15-a8b5-e063-6394a90a8189 | 2026-07-10 | Warnings | M017 |
| Intensive Healing Itch Relief | ITCH RELIEF CREAM | NeilMed Pharmaceuticals Inc | 563ef1d5-2180-bc45-e063-6294a90a813d | 2026-07-10 | Warnings | M017 |
| Quadriderm NF | HYDROCORTISONE | OPMX LLC | 5643f850-e0d4-d8d8-e063-6294a90a4260 | 2026-07-10 | 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 |