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 | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| Smart Care Hand Sanitizer Citrus Sunset | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 49f67a60-a6d8-0aa4-e063-6394a90a9859 | 2026-02-03 | Warnings | M003 |
| WIPES4HEALTH | BENZALKONIUM CHLORIDE | Bubble Marketing LLC | 5d6dd15b-d087-4f25-bd2b-035ecacd5f97 | 2026-02-03 | Warnings | M003 |
| Isopropyl alcohol | ISOPROPYL ALCOHOL | Concordance Healthcare Solutions, LLC | 1c051d6a-61a8-4a75-aeb6-7c1258bda2b2 | 2026-02-02 | Warnings, Adverse reactions | M003 |
| Dealmed Sterile Alcohol Prep Pads Large | ISOPROPYL ALCOHOL | Dealmed Medical Supplies, LLC. | 75908e89-abd9-4760-bd11-fb71133ae2c0 | 2026-02-02 | Warnings | M003 |
| Dealmed Sterile Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Dealmed Medical Supplies, LLC. | 0cdfc6b4-7d66-4333-b38d-c465d4864b5c | 2026-02-02 | Warnings | M003 |
| Medline | POVIDONE-IODINE | Medline Industries, LP | 494d7e97-a3a8-2c7a-e063-6394a90a3ae1 | 2026-02-02 | Warnings | M003 |
| Aplicare | ISOPROPYL ALCOHOL | Aplicare Products, LLC | 4950e07f-36a5-b6f5-e063-6294a90a8f98 | 2026-02-02 | Warnings | M003 |
| RELEEV Cold Sore Treatment | BENZALKONIUM CHLORIDE | Merix Pharmaceutical Corp. | fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | 2026-02-02 | Warnings | M003 63287-419 |
| WISH RUBBING ALCOHOL 91% | ISOPROPYL ALCOHOL | LJ Pharma | 07cba887-a568-4b92-91ab-2e7831f24ab5 | 2026-01-30 | Warnings | M003 |
| First Aid Antiseptic | POVIDONE-IODINE | Rite Aid Corporation | 2f8abb6f-460f-47bf-811d-734126aa3f0b | 2026-01-30 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Rite Aid Corporation | c074bbaf-2fd7-485a-9e22-a368d8dd4701 | 2026-01-30 | Warnings, Adverse reactions | M003 |
| Drs. pharmacy triple antibiotic plus lidocaine | BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, LIDOCAINE OINTMENT | OL PHARMA TECH, LLC | 49a73b0f-90d9-3a4b-e063-6294a90acfb0 | 2026-01-30 | Warnings | M003 |
| HAND SANITIZER WIPES | HAND SANITIZER WIPES | Shandong Baihe Sanitary Products Co., Ltd. | 49822c99-1181-ae42-e063-6394a90a8202 | 2026-01-29 | Warnings | M003 |
| WISH RUBBING ALCOHOL 50% | ISOPROPYL ALCOHOL | LJ Pharma | 15b4a45d-3dbf-48e4-8f90-15dca7e650d9 | 2026-01-29 | Warnings | M003 |
| WISH RUBBING ALCOHOL 50% Winter Green | ISOPROPYL ALCOHOL | LJ Pharma | fbb45bde-b733-4524-bfa9-ae819ad39973 | 2026-01-29 | Warnings | M003 |
| Walmart | ISOPROPYL ALCOHOL | Walmart Inc. | 1d75799d-081e-a38b-e063-6294a90adf35 | 2026-01-29 | Warnings | M003 |
| Liquid Bandage | BENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDE | Wal-Mart Stores, Inc. | f3911d79-3169-71c3-e053-2a95a90ae843 | 2026-01-29 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Amerifoods Trading Co | 38b15693-7e5f-4c85-915e-9937ea018a83 | 2026-01-29 | Warnings, Adverse reactions | M003 |
| IRIS | ISOPROPYL ALCOHOL | Amerifoods Trading Co | 100e0c3d-96eb-44af-8684-df45a8ab3065 | 2026-01-29 | Warnings, Adverse reactions | M003 |
| First Aid Antiseptic | FIRST AID ANTISEPTIC | Amerisource Bergen | 6719db46-a6e3-4f0a-828c-fe89a5187989 | 2026-01-29 | Warnings, Adverse reactions | 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 |