Orajel Cold Sore Touch Free - Single Dose
- Product NDC
- 10237-798
- 11-digit product format
- 102370798
- Labeler code
- 10237
- Product ID
- 10237-798_51b6fb8e-eeba-a04a-e063-6294a90a610f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium Chloride, Benzocaine
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-09-01
- Substance
- BENZALKONIUM CHLORIDE; BENZOCAINE
- Active strength
- 1.3; 50 mg/mL; mg/mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 10237-798-35 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 10237-798-35 | 367a005e9d99… | 383a685ebd0f… |
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 Cold Sore Touch Free - Single Dose
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZALKONIUM CHLORIDE | 1.3 mg/mL |
| BENZOCAINE | 50 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F5UM2KM3W7 | Internal UNII lookup |
| U3RSY48JW5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2572114 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ce40829e-941f-2548-e053-2995a90a1e0e | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-11-27 | Orajel Cold Sore Touch Free - Single Dose |
| 2024-11-27 | Orajel Cold Sore Touch Free - Single Dose |
| 2024-07-30 | Orajel Cold Sore Touch Free - Single Dose |
| 2024-07-30 | Orajel Cold Sore Touch Free - Single Dose |
| 2024-02-06 | Orajel Cold Sore Touch Free - Single Dose |
| 2024-02-06 | Orajel Cold Sore Touch Free - Single Dose |
| 2023-01-30 | Orajel Cold Sore Touch Free - Single Dose |
| 2023-01-30 | Orajel Cold Sore Touch Free - Single Dose |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-798-35 | Orajel Cold Sore Touch Free - Single Dose | 3.5 mL in 1 VIAL, SINGLE-DOSE | LIQUID | 3.5 | 6 | |
| 10237-798-35 | Orajel Cold Sore Touch Free - Single Dose | 6 in 1 PACKAGE | LIQUID | 6 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10237-798 | ORAJEL COLD SORE TOUCH FREE - SINGLE DOSE (BENZALKONIUM CHLORIDE, BENZOCAINE) LIQUID [CHURCH & DWIGHT CO., INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250330_ce40829e-941f-2548-e053-2995a90a1e0e.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 |
|---|---|---|---|---|---|---|
| Satogesic | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Sato Pharmaceutical Co., Ltd. | cb000134-92a4-4304-8ef0-0347190e1414 | 2026-07-31 | Warnings | M017 |
| Satogesic Hot | CAPSAICIN | Sato Pharmaceutical Co., Ltd. | 16b47cb5-ea5f-4514-9a89-141ee4cc60f8 | 2026-07-31 | Warnings | M017 |
| Satohap Cool and Hot Pads | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceutical Co., Ltd. | b6bf1eab-4ab9-f500-e053-2995a90a8d7b | 2026-07-31 | Warnings, Adverse reactions | M017 |
| SATOHAP COOL and HOT | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceuticals Co., Ltd. | 232a4c76-1a0c-2f4b-e063-6394a90a8849 | 2026-07-31 | Warnings, Adverse reactions | M017 |
| Cortizone 10 Itch Relief Massaging Rollerball | HYDROCORTISONE | Chattem, Inc. | 1e27682c-f856-41f1-9935-37540960a4c7 | 2026-07-31 | Warnings | M017 |
| Aspercreme with Lidocaine Dry | LIDOCAINE | Chattem, Inc. | 008abaaa-5e12-4246-a7f5-66f3966acf28 | 2026-07-30 | Warnings | M017 |
| ACOLYE Lidocaine Cream Topical Analgesia Cream | LIDOCAINE,MENTHOL | Guangdong Aimu Biological Technology Co., Ltd | 57deebf7-52f1-4256-e063-6294a90a75d5 | 2026-07-30 | Warnings | M017 |
| Icy Hot Performance No-Mess Pain Relief Cream | MENTHOL 16%, CAMPHOR 11% | Chattem, Inc. | 5e3e272a-c001-4f57-9535-521ccc85ae65 | 2026-07-30 | Warnings | M017 |
| Auixudin Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 57bc7b9e-e2f7-724b-e063-6394a90ab36f | 2026-07-29 | Warnings | M017 |
| Jinfahe Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Henan Enokon Medical Instrument Co., Ltd. | 57bcd9c5-767e-b634-e063-6394a90a2878 | 2026-07-29 | Warnings | M017 |
| Maximun Strength Lidocaine Patch Plus Menthol | LIDOCAINE, MENTHOL | Meijer Distribution Inc | d0468514-58ea-4d8f-b634-a65bf95c0316 | 2026-07-29 | Warnings | M017 |
| Oudetas Lidocaine Cream | LIDOCAINE CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 57ca9220-2778-790a-e063-6294a90af506 | 2026-07-29 | Warnings | M017 |
| Aspercreme Lidocaine No-Mess plus Lavender | LIDOCAINE HCL | Chattem, Inc. | 3948a3d2-ce04-4703-8709-211e75c9c38d | 2026-07-29 | Warnings | M017 |
| Aspercreme Professional Cream | LIDOCAINE HCL 4% | Chattem, Inc. | ef297864-5917-4645-8ec7-f2bc49e037e8 | 2026-07-29 | Warnings | M017 |
| LidoPro | LIDOCAINE AND MENTHOL | Clinic Pharma | cdfd6b39-b430-4e95-a0f7-682cf3d78b52 | 2026-07-28 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Clinic Pharma | 2b4d2105-b7ad-2695-e063-6394a90a999b | 2026-07-28 | Warnings | M017 |
| HEMPE Ice Muscle and Joint Gel | MENTHOL | Healthcare International Research Limited | 57aec922-1de4-c579-e063-6394a90af6c8 | 2026-07-28 | Warnings | M017 |
| Earths Care Pain Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | DLC Laboratories, Inc. | 5c3976da-a6cb-4b94-ae41-3e86b1ab13cb | 2026-07-28 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Preferred Pharmaceuticals Inc. | 9e7568b6-52ae-4f7a-9bfd-503fd80a297e | 2026-07-28 | Warnings | M017 |
| Aspercreme Lidocaine with Rosemary and Mint | LIDOCAINE HYDROCHLORIDE | Chattem, Inc. | 9d40bfea-85d0-4943-83e9-0c16e79a011c | 2026-07-28 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2572114 | benzalkonium chloride 0.13 % / benzocaine 5 % Topical Solution | PSN | ce40829e-941f-2548-e053-2995a90a1e0e | 6 |
| 2572114 | benzalkonium chloride 1.3 MG/ML / benzocaine 50 MG/ML Topical Solution | SCD | ce40829e-941f-2548-e053-2995a90a1e0e | 6 |
| 2572114 | benzalkonium chloride 0.13 % / benzocaine 5 % Topical Solution | SY | ce40829e-941f-2548-e053-2995a90a1e0e | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10237-798-35 | 10237079835 | 6 VIAL, SINGLE-DOSE in 1 PACKAGE (10237-798-35) / 3.5 mL in 1 VIAL, SINGLE-DOSE | 2021-09-01 | 0000-00-00 | No | No | Current |