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 Pain Relief Roll-On | LIDOCAINE 4% | Pharma Nobis, LLC | 4f6d9a51-c42e-ca88-e063-6394a90a8659 | 2026-04-14 | Warnings | M017 |
| Hot/Cold Menthol 16% Roll-On | HOT/COLD MENTHOL 16% ROLL-ON | Pharma Nobis, LLC | 4f6f5a0b-3bfa-289e-e063-6294a90a94b3 | 2026-04-14 | Warnings | M017 |
| Sting Relief Swab | BENZOCAINE | 4 Visions LLC | 4f76a8c5-fde6-eee0-e063-6394a90a09f8 | 2026-04-14 | Warnings | M017 |
| Signature Pain Relief Cream | 4% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 4f555b8f-5193-e685-e063-6294a90a7ba2 | 2026-04-13 | Warnings | M017 |
| Deep Numbing Cream | MENTHOL | YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD | 7943559b-de10-4214-96dc-f9cbac828f46 | 2026-04-13 | Warnings | M017 |
| Hydrocortisone Cream 1% | HYDROCORTISONE CREAM 1% WITH ALOE | Publix Super Markets Inc. | 3c45a654-7fec-55b3-e063-6294a90a184b | 2026-04-13 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1% | AMERISOURCE BERGEN | 4f5aea1c-ae51-4e1a-e063-6294a90a6aa1 | 2026-04-13 | Warnings | M017 |
| ActivICE | MENTHOL | Medline Industries, LP | 8465b443-abe9-78fb-e053-2a91aa0ac1d8 | 2026-04-13 | Warnings | M017 |
| 4Jointz | MENTHOL | ARP(USA) Pty Ltd | 94a5b5f5-abf7-40b3-9dd7-43e2c22f138e | 2026-04-13 | Warnings | M017 |
| Sumifun Pain Relief Creams | METHYL SALICLATE CAPSAICIN CAMPHOR | Guchutang Biotechnology (Longyan) Co., Ltd | 4f3dd96a-d843-d810-e063-6394a90a188e | 2026-04-12 | Warnings | M017 |
| BonicaEaseX 24 Hour Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co., Ltd. | 17fc0cd1-710d-45e6-9513-d7100e3adb42 | 2026-04-10 | Warnings | M017 |
| BonicaEaseX Colorless Roll-On Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co.,Ltd | acf460b4-1b41-4b30-a74a-6c3613119d8e | 2026-04-10 | Warnings | M017 |
| BonicaEaseX Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co.,Ltd | 4d84b4fb-8f55-4b2b-b261-858edb7f3144 | 2026-04-10 | Warnings | M017 |
| HealthWise Pain Relief Gel Patch | CAPSAICIN, MENTHOL | Veridian Healthcare | f5484151-b6da-4f64-867f-87160a4ec2d6 | 2026-04-10 | Warnings | M017 |
| LidoTape | LIDOCAINE 4% | V2 Pharma LLC | ed18b4f7-6a2c-4dce-9b53-e485569093c5 | 2026-04-09 | Warnings | M017 |
| TheraCare Lidocaine Pain Relief | LIDOCAINE | Veridian Healthcare | 4f112ab2-b67a-a3e2-e063-6394a90acb60 | 2026-04-09 | Warnings | M017 |
| TheraCare Pain Relief | MENTHOL | Veridian Healthcare | 4f11aa1e-de53-a3b0-e063-6294a90a2fe4 | 2026-04-09 | Warnings | M017 |
| TheraCare 2X Medicated Pain Relief | LIDOCAINE, MENTHOL | Veridian Healthcare | 4f11fca1-1949-ab8e-e063-6394a90ac627 | 2026-04-09 | Warnings | M017 |
| TheraCare Medicated Pain Relief | CAMPHOR, MENTHOL, METHYL SALICYLATE | Veridian Healthcare | 4f125062-af89-40d3-e063-6394a90a27ef | 2026-04-09 | Warnings | M017 |
| DRMITSUI ECZEMA RELIEF | HYDROCORTISONE 1% ECZEMA RELIEF | Jiangxi Yudexi Pharmaceutical Co., LTD | 4eee7637-3a28-e0bd-e063-6294a90ae1a4 | 2026-04-08 | 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 |