FDA.reportPublic FDA data

RELEEV Cold Sore Treatment

Product NDC
63287-419
Requested package NDC
63287-419-01
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

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.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…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 table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049254Internal RxNorm lookup
1095485Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcef2fd3-2f32-4fb0-b396-ba4481ca4ccfAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63287-419-012025-01-30RELEEV 1 day Cold sore Symptom Treatment
63287-419-032025-01-30RELEEV 1 day Cold sore Symptom Treatment
63287-419-062025-01-30RELEEV 1 day Cold sore Symptom Treatment
63287-419-332025-01-30RELEEV 1 day Cold sore Symptom Treatment
63287-419-012022-07-15RELEEV 1 day Cold sore Symptom Treatment
63287-419-032022-07-15RELEEV 1 day Cold sore Symptom Treatment
63287-419-062022-07-15RELEEV 1 day Cold sore Symptom Treatment
63287-419-332022-07-15RELEEV 1 day Cold sore Symptom Treatment
63287-419-012022-01-28RELEEV 1 day Cold sore Symptom Treatment
63287-419-032022-01-28RELEEV 1 day Cold sore Symptom Treatment
63287-419-062022-01-28RELEEV 1 day Cold sore Symptom Treatment
63287-419-332022-01-28RELEEV 1 day Cold sore Symptom Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63287-419-01RELEEV Cold Sore Treatment1 in 1 POUCHLIQUID119
63287-419-01RELEEV Cold Sore Treatment1 in 1 BLISTER PACKLIQUID119
63287-419-03RELEEV Cold Sore Treatment1 in 1 BLISTER PACKLIQUID119
63287-419-03RELEEV Cold Sore Treatment3 mL in 1 BOTTLE, DROPPERLIQUID319
63287-419-06RELEEV Cold Sore Treatment6 mL in 1 BOTTLE, DROPPERLIQUID619
63287-419-06RELEEV Cold Sore Treatment1 in 1 BLISTER PACKLIQUID119
63287-419-20RELEEV Cold Sore Treatment1 in 1 CARTONLIQUID119
63287-419-20RELEEV Cold Sore Treatment60 mL in 1 BOTTLE, SPRAYLIQUID6019
63287-419-33RELEEV Cold Sore Treatment3 mL in 1 BOTTLE, DROPPERLIQUID319
63287-419-33RELEEV Cold Sore Treatment1 in 1 BLISTER PACKLIQUID119

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W7RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]8
BenzalkoniumACTIVE MOIETY7N6JUD5X6YRELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]8
Echinacea purpurea flowering topINACTIVE INGREDIENT2EMS3QFX65RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]8
HYPROMELLOSE 2910 (4000 MPA.S)INACTIVE INGREDIENTRN3152OP35RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]8
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TRELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]8
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ4RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]8
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHRELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]8
WaterINACTIVE INGREDIENT059QF0KO0RRELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63287-419RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]17Current NDC, Legacy NDC, 10 package rows20220717_fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf.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.

Matched openFDA labels page 41 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH ISOPROPYL ALCOHOLWISH ISOPROPYL ALCOHOLClick Products LLC484befce-ecfe-5514-e063-6294a90a169c2026-01-13WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 32ozWISH RUBBING ALCOHOL 32OZ 70%CLICK PRODUCTS LLC4836b564-0b8c-2fb4-e063-6394a90a9c4a2026-01-13WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEDealMed Medical Supplies LLC6d1ddf10-8873-4781-9165-bb1c4bbccfc92026-01-13WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e2c51699-d4da-5b88-e053-2995a90afd7f2026-01-12WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e297b705-8070-f7c3-e053-2a95a90a8c5b2026-01-12WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHydrox Laboratories6e5709b4-cc56-4768-b704-1d9b0e3efec72026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol 50%ISOPROPYL ALCOHOL 50%Hydrox Laboratories930bb3a3-5ca3-414c-b4fb-c71ee17fc7462026-01-12WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINESion Biotext Medical Ltd04438f9e-302c-431b-b3ad-d2c50ca01ad82026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratoriesf2f07464-6bd5-434c-8dea-0ba659c0e5492026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 70%ISOPROPYL ALCOHOL WITH WINTERGREEN 70%Hydrox Laboratories5845f723-8866-4738-bec6-621041899f572026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratories2042cf29-52c5-4f1e-aae6-78e025994d182026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 50%ISOPROPYL ALCOHOL WITH WINTERGREEN 50%Hydrox Laboratories3a15a900-2b48-487f-b252-a1a1e0d0abfc2026-01-12WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLDiscount Drug Mart37a6c0fb-e9c4-4a95-9539-ca5766b3a7012026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLDiscount Drug Mart7ac6b062-b471-4653-9d6f-de2ca8f8b0142026-01-12WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEDiscount Drug Mart7663654d-3697-40aa-8357-0978be7773a42026-01-12WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLEpic Medical Supply Corp.88e6418c-ceb3-4bd6-8765-b476d8bf3ff32026-01-12WarningsExact identifier
application number: M003
WISH HYDROGEN PEROXIDEWISH HYDROGEN PEROXIDE 3%CLICK PRODUCTS LLC48370aaa-da08-a2ef-e063-6394a90a62b32026-01-12WarningsExact identifier
application number: M003
SANMO-BLMOISTURIZING SANITIZER WITH BLUE BEADSBeacon Promotions, Inc.1eb96fb8-d750-9241-e063-6394a90a1cdd2026-01-12WarningsExact identifier
application number: M003
Unscented SanitizerUNSCENTED SANITIZERBeacon Promotions, Inc.1f96aecf-8ca2-aa27-e063-6394a90abb792026-01-12WarningsExact identifier
application number: M003
Scented Hand SanitizerSCENTED HAND SANITIZERBeacon Promotions, Inc.1f95444c-7587-a07e-e063-6394a90af5342026-01-12WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNfcef2fd3-2f32-4fb0-b396-ba4481ca4ccf19
1095485Releev Cold Sore 0.13 % Topical SolutionPSNfcef2fd3-2f32-4fb0-b396-ba4481ca4ccf19
1095485benzalkonium chloride 1.3 MG/ML Topical Solution [Releev Cold Sore]SBDfcef2fd3-2f32-4fb0-b396-ba4481ca4ccf19
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDfcef2fd3-2f32-4fb0-b396-ba4481ca4ccf19
1049254benzalkonium chloride 0.13 % Topical SolutionSYfcef2fd3-2f32-4fb0-b396-ba4481ca4ccf19
1095485Releev Cold Sore 0.13 % Topical SolutionSYfcef2fd3-2f32-4fb0-b396-ba4481ca4ccf19
1095485Releev Cold Sore 1.3 MG/ML Topical SolutionSYfcef2fd3-2f32-4fb0-b396-ba4481ca4ccf19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63287-419-01632870419011 POUCH in 1 BLISTER PACK (63287-419-01) / 1 BOTTLE, DROPPER in 1 POUCH / 1 mL in 1 BOTTLE, DROPPER1 pouch2006-06-010000-00-00NoNoCurrent