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 |
|---|---|---|---|---|---|---|
| Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION | MENTHOL,PRAMOXINE HYDROCHLORIDE | Rida LLC | b62d09e4-7ced-49a9-8c83-3a8ef580f25a | 2026-06-23 | Warnings | M017 |
| Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION | PRAMOXINE HYDROCHLORIDE | Rida LLC | 5b2cb1bd-2f1e-4670-b40e-6c058bfd12a2 | 2026-06-23 | Warnings | M017 |
| Pain Relieving cleansing spary | BENZALKONIUM CHLORIDE AND LIDOCAINE HCI | Trifecta Pharmaceuticals USA, LLC. | 48edbb8d-0c35-91d8-e063-6394a90a71b8 | 2026-06-19 | Warnings | M017 |
| Pain Relief | MENTHOL | Trifecta Pharmaceuticals USA, LLC. | 493ab515-5cda-7b5a-e063-6294a90a295b | 2026-06-19 | Warnings | M017 |
| Tiger Balm Muscle Rub | METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) | Haw Par Healthcare Ltd. | 011fc383-10bc-44cf-a67c-4be45fef33e0 | 2026-06-19 | Warnings | M017 |
| CVS Health Scalp Relief | SALICYLIC ACID | CVS Health | 8de46015-817c-4cd9-95f8-293424f2a5c4 | 2026-06-19 | Warnings | M017 |
| Careland Kinesiology Dual Action Pain Relieving Tape | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | 67e0b3c5-e88e-4c48-a1e8-39f502ac249d | 2026-06-18 | Warnings | M017 |
| Zensa | LIDOCAINE | Alera Skin Care Products Inc. | 549348ec-2eb2-3781-e063-6294a90a2f4a | 2026-06-18 | Warnings | M017 |
| SprayPain Away | CAPSAICIN | Proximity Capital Partners LLC dba Asutra | c603e999-2316-496a-e053-2995a90ab4ed | 2026-06-17 | Warnings | M017 |
| SprayPain Away Lavender | CAPSAICIN | Proximity Capital Partners LLC dba Asutra | 547e2167-ade0-ac7e-e063-6294a90a18ea | 2026-06-17 | Warnings | M017 |
| Roll Pain Away | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547e647b-0205-221c-e063-6294a90a757c | 2026-06-17 | Warnings | M017 |
| Roll Pain Away Lemongrass | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547ef5c0-bc31-d83e-e063-6394a90abfa6 | 2026-06-17 | Warnings | M017 |
| Roll Pain Away Lavender | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547ef2d9-f5c7-9de1-e063-6394a90a218b | 2026-06-17 | Warnings | M017 |
| Velloryn EXTRA STRENGTH NEUROPATHY | VELLORYN EXTRA STRENGTH NEUROPATHY | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 547f755f-c65c-37ef-e063-6394a90aa220 | 2026-06-17 | Warnings | M017 |
| Neoteric Diabetic Skin Care 4 oz. | DIMETHICONE | RNA PHARMA LLC | 536f4e79-201b-7100-e063-6394a90a4f82 | 2026-06-16 | Warnings | M017 |
| Medi First Extra Strength Itch Relief | DIPHENHYDRAMINE, ZINC ACETATE | Unifirst First Aid Corporation | 54614e5b-8c72-d308-e063-6294a90a405d | 2026-06-16 | Warnings | M017 |
| AXE BRAND MEDICATED | MENTHOL, CAMPHOR AND METHYL SALICYLATE | LEUNG KAI FOOK MEDICAL CO PTE LTD | e4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b0 | 2026-06-16 | Warnings | M017 |
| Blue Ice Analgesic | MENTHOL | Delon Laboratories (1990) Ltd | 184ed488-6e62-40c6-bb71-1d523280fd6b | 2026-06-16 | Warnings | M017 |
| Medi-First Hydrocortisone 1 % Anti-Itch Cream | HYDROCORTISONE | Unifirst First Aid Corporation | 49f04e5d-746d-cbe9-e063-6294a90a7e88 | 2026-06-16 | Warnings | M017 |
| Lidozall Pro | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | ecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff | 2026-06-16 | 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 |