FDA.reportPublic FDA data

RELEEV Cold Sore Treatment

Product NDC
63287-419
Requested package NDC
63287-419-20
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

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 1 of 116 · 2,301 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
application number: M003
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)961488a8-8ff3-4fa5-8846-6201e0eb52402026-08-12WarningsExact identifier
application number: M003
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
application number: M003
Ethyl alcoholETHYL ALCOHOLStrategic Sourcing Services LLC4fec6f1f-0249-423f-bd3c-427aa6924c6f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M003
antibacterial hand wipes (JUICY WATERMELON)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.5883c43d-212b-af39-e063-6394a90ad6522026-08-08WarningsExact identifier
application number: M003
LIGHTS Antiseptic and Pain Relieving Prep PadISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.91cc7334-f610-487d-a895-3dda78c3372e2026-08-07WarningsExact identifier
application number: M003
CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSKETHYL ALCOHOLCVS Pharmacy, Inc.60128fc3-b127-44ee-9e9b-384d322d213a2026-08-07WarningsExact identifier
application number: M003
CVS Beauty Hydrating Hand Sanitizer Sea Salt and LavenderETHYL ALCOHOLCVS Pharmacy, Inc.6c160826-ad98-4390-a07b-c92a2ae5b1812026-08-07WarningsExact identifier
application number: M003
antibacterial hand wipes (2257C)ANTIBACTERIAL HAND WIPES (2257C)Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585a1c36-7bdc-4d4f-e063-6394a90ad6d22026-08-06WarningsExact identifier
application number: M003
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-06WarningsExact identifier
application number: M003
antibacterial hand wipes (Angel)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585c4a14-8dc9-3a08-e063-6394a90ab4f52026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer ROSEWATER SPRITZALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585cb4fa-6016-1550-e063-6294a90a514d2026-08-06WarningsExact identifier
application number: M003
CharmTex Lightly Scented AntibacterialBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltd4b642dfa-f044-4410-81e4-142f0497f0f32026-08-06WarningsExact identifier
application number: M003
antibacterial wipes 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.585dec39-ccb8-d2ba-e063-6394a90aec0f2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer PASSION MANGO SPLASHALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585df6ce-4625-d5d2-e063-6394a90a7fcb2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer LILY SPRINGSALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e0c24-7f5f-4ba7-e063-6294a90a75972026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer WATERMELON POPALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e3ced-fa45-8576-e063-6294a90af50f2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer ALOE BREEZEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e647c-2904-2d3f-e063-6394a90a2b792026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer LAVENDER DREAMALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e8222-fad5-4409-e063-6394a90a9c602026-08-06WarningsExact 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 formatDescriptionMarketing startSampleExclude flagStatus
63287-419-20632870419201 BOTTLE, SPRAY in 1 CARTON (63287-419-20) / 60 mL in 1 BOTTLE, SPRAY2026-04-10NoNoCurrent