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 |
|---|---|---|---|---|---|---|
| EVERLIT CARE PRODUCTS BURN RELIEF | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 5371dae4-ea63-46cc-ac26-5418f359c63e | 2026-05-04 | Warnings | M017 |
| EVERLIT CARE BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | a2cf1726-3dc9-4624-b898-ac91fb4cbdb2 | 2026-05-04 | Warnings | M017 |
| FIRSTAR BURN | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 186343c5-2e71-49c4-8d64-5fb3131239fa | 2026-05-04 | Warnings | M017 |
| Feminine Anti Itch Cream | BENZOCAINE,RESORCINOL | TRIFECTA PHARMACEUTICALS USA LLC | 50c3acbf-b873-908a-e063-6294a90a66b7 | 2026-05-01 | Warnings | M017 |
| 24 7 Relief and Recovery Pain Relieving | MENTHOL, UNSPECIFIED FORM | Triplicare Inc | 53ca807b-3ec2-4b5e-aa5a-6dcb756bb423 | 2026-04-30 | Warnings | M017 |
| FIRST AID BURN | LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE | 4 Visions LLC | 50b1351d-72dd-e0c9-e063-6294a90ac743 | 2026-04-30 | Warnings | M017 |
| TheraCare Flexible Pain Relieving | LIDOCAINE | Veridian Healthcare | 4f108002-2cae-0671-e063-6294a90ab6cf | 2026-04-30 | Warnings | M017 |
| Pain Relief Gel Roll On | MENTHOL | Trifecta Pharmaceuticals USA | 50b1a420-d5cd-6d61-e063-6294a90a0451 | 2026-04-30 | Warnings | M017 |
| Dr. Numb | LIDOCAINE AND BENZETHONIUM CHLORIDE CREAM | Shinpharma Inc | d8cdccdb-775b-4970-a6ea-50b62df221d6 | 2026-04-30 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Padagis Israel Pharmaceuticals Ltd | 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 | 2026-04-29 | Warnings | M017 |
| anti itch | HYDROCORTISONE | HyVee Inc | e1db3641-2e83-4fec-8394-98d0d876ce0d | 2026-04-29 | Warnings | M017 |
| Eagle Brand Medicated Roll On | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 50805eee-33b3-86bd-e063-6294a90a77d8 | 2026-04-28 | Warnings | M017 |
| FixMySkin Healing Balm Vanilla Flavor | HYDROCORTISONE | Lovely Skin, Inc. | 52f7a561-a0b5-4562-a588-d74fd874b83a | 2026-04-28 | Warnings | M017 |
| Blue Star Medicated | CAMPHOR | Focus Consumer Healthcare, LLC | 56df008e-a23b-4870-e054-00144ff8d46c | 2026-04-27 | Warnings | M017 |
| Eagle Brand Muscle Rub | MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 06cb845c-cc53-1f1d-e063-6394a90a8c01 | 2026-04-27 | Warnings | M017 |
| Eagle Brand Medicated Oil Aromatic | CAMPHOR, MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 0ef7c3aa-94a3-9fe9-e063-6394a90ab13d | 2026-04-27 | Warnings | M017 |
| Eagle Brand Medicated Oil | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 5071f145-49f7-0855-e063-6394a90a8f26 | 2026-04-27 | Warnings | M017 |
| Eagle Brand Medicated Oil Refresh | CAMPHOR, MENTHOL | PT. EAGLE INDO PHARMA | 09260c31-56a3-07aa-e063-6394a90a95fd | 2026-04-27 | Warnings | M017 |
| Eagle Brand Muscle Rub | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 5072ad57-9fa7-ddba-e063-6394a90a319b | 2026-04-27 | Warnings | M017 |
| Eagle Brand Medicated Roll On Refresh | CAMPHOR, MENTHOL | PT. EAGLE INDO PHARMA | 09235f26-2262-6ca2-e063-6394a90ad8f1 | 2026-04-27 | 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 |