RELEEV Cold Sore Treatment
- Product NDC
- 63287-419
- 11-digit product format
- 632870419
- Labeler code
- 63287
- Product ID
- 63287-419_4f110f71-5b1b-b9f2-e063-6294a90a2baa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium Chloride
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Merix Pharmaceutical Corp.
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2006-06-01
- Substance
- BENZALKONIUM CHLORIDE
- Active strength
- 1.3 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63287-419 | 63287-419-03 | D | Discontinued by firm | 2026-10-23 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63287-419-33 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63287-419-01 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63287-419-03 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63287-419-06 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63287-419-33 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63287-419-01 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63287-419-03 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63287-419-06 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63287-419-33 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63287-419-01 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63287-419-03 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63287-419-06 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63287-419-33 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63287-419-01 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63287-419-03 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63287-419-06 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63287-419-33 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63287-419-01 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63287-419-03 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63287-419-06 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63287-419-33 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63287-419-01 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63287-419-03 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63287-419-06 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63287-419-33 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63287-419-03 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63287-419-01 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63287-419-06 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63287-419-33 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63287-419-03 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63287-419-01 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63287-419-06 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63287-419-33 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63287-419-03 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63287-419-01 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63287-419-06 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63287-419-03 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63287-419-03 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63287-419-03 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63287-419-06 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63287-419-03 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63287-419-01 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63287-419-33 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63287-419-06 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63287-419-03 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63287-419-01 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63287-419-33 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
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
- RELEEV Cold Sore Treatment
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZALKONIUM CHLORIDE | 1.3 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F5UM2KM3W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 63287-419-01 | 2025-01-30 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-03 | 2025-01-30 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-06 | 2025-01-30 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-33 | 2025-01-30 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-01 | 2022-07-15 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-03 | 2022-07-15 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-06 | 2022-07-15 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-33 | 2022-07-15 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-01 | 2022-01-28 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-03 | 2022-01-28 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-06 | 2022-01-28 | RELEEV 1 day Cold sore Symptom Treatment |
| 63287-419-33 | 2022-01-28 | RELEEV 1 day Cold sore Symptom Treatment |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63287-419-01 | RELEEV Cold Sore Treatment | 1 in 1 POUCH | LIQUID | 1 | 19 | |
| 63287-419-01 | RELEEV Cold Sore Treatment | 1 in 1 BLISTER PACK | LIQUID | 1 | 19 | |
| 63287-419-03 | RELEEV Cold Sore Treatment | 1 in 1 BLISTER PACK | LIQUID | 1 | 19 | |
| 63287-419-03 | RELEEV Cold Sore Treatment | 3 mL in 1 BOTTLE, DROPPER | LIQUID | 3 | 19 | |
| 63287-419-06 | RELEEV Cold Sore Treatment | 6 mL in 1 BOTTLE, DROPPER | LIQUID | 6 | 19 | |
| 63287-419-06 | RELEEV Cold Sore Treatment | 1 in 1 BLISTER PACK | LIQUID | 1 | 19 | |
| 63287-419-20 | RELEEV Cold Sore Treatment | 1 in 1 CARTON | LIQUID | 1 | 19 | |
| 63287-419-20 | RELEEV Cold Sore Treatment | 60 mL in 1 BOTTLE, SPRAY | LIQUID | 60 | 19 | |
| 63287-419-33 | RELEEV Cold Sore Treatment | 3 mL in 1 BOTTLE, DROPPER | LIQUID | 3 | 19 | |
| 63287-419-33 | RELEEV Cold Sore Treatment | 1 in 1 BLISTER PACK | LIQUID | 1 | 19 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Povidone Iodine Prep | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | 47a5726f-d314-50d9-e054-00144ff8d46c | 2023-10-23 | Warnings | M003 |
| Povidone Iodine Scrub | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | 47a5690c-08ad-5092-e054-00144ff8d46c | 2023-10-23 | Warnings | M003 |
| Alcohol Prep Pad | ISOPROPYL ALCOHOL | Jianerkang Medical Co., Ltd | 1c7f9a00-6600-4b0d-af11-fa776b22e678 | 2023-10-23 | Warnings | M003 |
| Alcohol Prep Pad | ISOPROPYL ALCOHOL | Jianerkang Medical Co., Ltd | 1c9f2c8b-6ed6-4e54-a151-5be4acb290e4 | 2023-10-23 | Warnings | M003 |
| Alcohol Prep Pad | ISOPROPYL ALCOHOL | Jianerkang Medical Co., Ltd | 878bfaa7-d553-40db-8311-19010930abd9 | 2023-10-23 | Warnings | M003 |
| Alcohol Prep Pad | ISOPROPYL ALCOHOL | Jianerkang Medical Co., Ltd | c1273e40-5c09-435b-adf3-e352fdd01e9e | 2023-10-23 | Warnings | M003 |
| POVIDONE IODINE SCRUB SWABSTICK 3s | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | 65783da9-acca-41c7-860b-1de108edc583 | 2023-10-23 | Warnings | M003 |
| Obstetrical Towelette | BENZALKONIUM CHLORIDE | Jianerkang Medical Co., Ltd | 8db4eb14-85b6-4c8e-9623-39a43b3827a1 | 2023-10-23 | Warnings | M003 |
| POVIDONE IODINE PREP PAD Sterile | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | ac3aa401-a124-4eb7-9598-119be0f24ddd | 2023-10-23 | Warnings | M003 |
| Alcohol Prep Pad | ISOPROPYL ALCOHOL | Jianerkang Medical Co., Ltd | c13af96e-f76a-4577-8d57-811ccc652738 | 2023-10-23 | Warnings | M003 |
| Povidone-Iodine Prep Pad | POVIDONE-IODINE | Cardinal Health 200, Inc. | 06c8a6f6-2fc8-4292-a3b5-6311a918a521 | 2023-10-23 | Warnings | M003 |
| Antiseptic BZK Towelette | BENZALKONIUM CHLORIDE | Cardinal Health 200, Inc. | 8dd79ffe-f742-438c-9814-612f900ad6a9 | 2023-10-23 | Warnings | M003 |
| Povidone Iodine Topical Solution Paint | POVIDONE IODINE 10% | Jianerkang Medical Co., Ltd | f231a572-a99d-4146-afa3-e73ea1cee027 | 2023-10-22 | Warnings | M003 |
| Povidone Iodine Topical Solution Paint | POVIDONE IODINE 10% | Jianerkang Medical Co., Ltd | 42778607-6170-4a5e-94d0-5e6cd064eec6 | 2023-10-22 | Warnings | M003 |
| Alcohol | ISOPROPYL ALCOHOL | Jianerkang Medical Co., Ltd | 76048b01-28f3-4e43-9da9-974b2b511a10 | 2023-10-22 | Warnings | M003 |
| GENUINE FIRST AID Antiseptic Hand Sanitizer | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | d25f02f1-268c-44d8-9a55-c6efcbe8eed1 | 2023-10-19 | Warnings | M003 |
| Brompton and Langley Moisturizing Hand Sanitizer Lavnder Vanilla | ALCOHOL | Ganzhou Olivee Cosmetic Co., Ltd. | 90bd3436-a8bc-4c19-a300-d59236a8de27 | 2023-10-19 | Warnings | M003 |
| Up and Up 70 Isopropyl Alcohol Wipes | ISOPROPYL ALCOHOL | Target Corporation | becc8fe3-eaf5-4429-b462-a87dd09c4db8 | 2023-10-17 | Warnings | M003 |
| Henry Schein Povidone-Iodine Swabsticks | POVIDONE-IODINE | Henry Schein, Inc. | 766ad4df-2100-4f26-bd8b-5c5a0918698e | 2023-10-13 | Warnings | M003 |
| GoodSense Alcohol Swabs | ISOPROPYL ALCOHOL | Geiss, Destin and Dunn | 968bab9f-5b74-270b-e053-2995a90a0df4 | 2023-10-13 | Warnings | M003 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049254 | benzalkonium chloride 0.13 % Topical Solution | PSN | fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | 19 |
| 1095485 | Releev Cold Sore 0.13 % Topical Solution | PSN | fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | 19 |
| 1095485 | benzalkonium chloride 1.3 MG/ML Topical Solution [Releev Cold Sore] | SBD | fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | 19 |
| 1049254 | benzalkonium chloride 1.3 MG/ML Topical Solution | SCD | fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | 19 |
| 1049254 | benzalkonium chloride 0.13 % Topical Solution | SY | fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | 19 |
| 1095485 | Releev Cold Sore 0.13 % Topical Solution | SY | fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | 19 |
| 1095485 | Releev Cold Sore 1.3 MG/ML Topical Solution | SY | fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | 19 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63287-419-01 | 63287041901 | 1 POUCH in 1 BLISTER PACK (63287-419-01) / 1 BOTTLE, DROPPER in 1 POUCH / 1 mL in 1 BOTTLE, DROPPER | 1 pouch | 2006-06-01 | 0000-00-00 | No | No | Current |
| 63287-419-03 | 63287041903 | 1 BOTTLE, DROPPER in 1 BLISTER PACK (63287-419-03) > 3 mL in 1 BOTTLE, DROPPER | 2006-06-01 | 0000-00-00 | No | No | Current | |
| 63287-419-06 | 63287041906 | 1 BOTTLE, DROPPER in 1 BLISTER PACK (63287-419-06) / 6 mL in 1 BOTTLE, DROPPER | 2006-06-01 | 0000-00-00 | No | No | Current | |
| 63287-419-20 | 63287041920 | 1 BOTTLE, SPRAY in 1 CARTON (63287-419-20) / 60 mL in 1 BOTTLE, SPRAY | 2026-04-10 | No | No | Current | ||
| 63287-419-33 | 63287041933 | 1 BOTTLE, DROPPER in 1 BLISTER PACK (63287-419-33) / 3 mL in 1 BOTTLE, DROPPER | 2018-08-21 | 0000-00-00 | No | No | Current |