Home NDC 63287-419-01 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 date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 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 table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049254 Internal RxNorm lookup 1095485 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table 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# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63287-419 RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.] 17 Current NDC, Legacy NDC, 10 package rows 20220717_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 9 of 115 · 2,286 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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