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 |
|---|---|---|---|---|---|---|
| Benzalkonium Chloride | SANITIZING HAND WIPES | ALO NEW YORK LLC | d3afde78-b9f6-3648-e053-2a95a90a4024 | 2026-01-15 | Warnings | M003 |
| BIOPURE Hand Sanitizer Spray-Coastal Glow | HAND SANITIZER SPRAY | Quest USA Corp | 48254577-9f1e-9389-e063-6394a90a92f1 | 2026-01-15 | Warnings | M003 |
| hi peach layne | ETHYL ALCOHOL | Zhejiang Jinghui Cosmetics Share Co., Ltd. | 487a4c8e-4fb3-6bff-e063-6294a90abd53 | 2026-01-15 | Warnings | M003 |
| Gold Bond Hydrating Hand Sanitizer | ETHYL ALCOHOL | Chattem, Inc. | 96fe0191-0d34-4bf3-8f93-0e64764c353a | 2026-01-14 | Warnings | M003 |
| Alcohol Prep Awabs | ISOPROPYL ALCOHOL | Enlightening Pallet Industry Co., Limited | 26c7db1e-86a9-8765-e063-6294a90a634f | 2026-01-14 | Warnings | M003 |
| Caring Hands | HAND MOISTURIZING SANITIZER | Gleeco Labs LLC | 2ced5dc5-47dd-1b71-e063-6394a90a0e3d | 2026-01-14 | Warnings | M003 |
| Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | DealMed Medical Supplies LLC | 04e6edb5-07ef-4ed4-ba68-ed183386b5ab | 2026-01-13 | Warnings | M003 |
| Dermoplast First Aid | BENZETHONIUM CHLORIDE AND BENZOCAINE | Advantice Health, LLC | ec93011d-7069-4021-8dd2-3d51eb6026e1 | 2026-01-13 | Warnings | M003 |
| WISH ISOPROPYL ALCOHOL | WISH ISOPROPYL ALCOHOL | Click Products LLC | 484befce-ecfe-5514-e063-6294a90a169c | 2026-01-13 | Warnings | M003 |
| WISH RUBBING ALCOHOL 32oz | WISH RUBBING ALCOHOL 32OZ 70% | CLICK PRODUCTS LLC | 4836b564-0b8c-2fb4-e063-6394a90a9c4a | 2026-01-13 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | DealMed Medical Supplies LLC | 6d1ddf10-8873-4781-9165-bb1c4bbccfc9 | 2026-01-13 | Warnings | M003 |
| AVANCE INCONTINENCE CARE | BENZETHONIUM CHLORIDE | SMART CHOICE MEDICAL INC. | e2c51699-d4da-5b88-e053-2995a90afd7f | 2026-01-12 | Warnings | M003 |
| AVANCE INCONTINENCE CARE | BENZETHONIUM CHLORIDE | SMART CHOICE MEDICAL INC. | e297b705-8070-f7c3-e053-2a95a90a8c5b | 2026-01-12 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Hydrox Laboratories | 6e5709b4-cc56-4768-b704-1d9b0e3efec7 | 2026-01-12 | Warnings | M003 |
| Isopropyl Alcohol 50% | ISOPROPYL ALCOHOL 50% | Hydrox Laboratories | 930bb3a3-5ca3-414c-b4fb-c71ee17fc746 | 2026-01-12 | Warnings | M003 |
| Povidone Iodine | POVIDONE-IODINE | Sion Biotext Medical Ltd | 04438f9e-302c-431b-b3ad-d2c50ca01ad8 | 2026-01-12 | Warnings | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Hydrox Laboratories | f2f07464-6bd5-434c-8dea-0ba659c0e549 | 2026-01-12 | Warnings | M003 |
| Isopropyl Alcohol with Wintergreen 70% | ISOPROPYL ALCOHOL WITH WINTERGREEN 70% | Hydrox Laboratories | 5845f723-8866-4738-bec6-621041899f57 | 2026-01-12 | Warnings | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Hydrox Laboratories | 2042cf29-52c5-4f1e-aae6-78e025994d18 | 2026-01-12 | Warnings | M003 |
| Isopropyl Alcohol with Wintergreen 50% | ISOPROPYL ALCOHOL WITH WINTERGREEN 50% | Hydrox Laboratories | 3a15a900-2b48-487f-b252-a1a1e0d0abfc | 2026-01-12 | 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 |