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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
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 table
Package NDC	Product	Description	Form	Quantity	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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzalkonium Chloride	ACTIVE INGREDIENT	F5UM2KM3W7	RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]	8
Benzalkonium	ACTIVE MOIETY	7N6JUD5X6Y	RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]	8
Echinacea purpurea flowering top	INACTIVE INGREDIENT	2EMS3QFX65	RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]	8
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]	8
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]	8
Potassium Sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]	8
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]	8
Water	INACTIVE INGREDIENT	059QF0KO0R	RELEEV COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) LIQUID [MERIX PHARMACEUTICAL CORP.]	8

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 47 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Iodine Prep Pad Antiseptic	POVIDONE-IODINE	Yiwu Ori-Power Medtech Co.,Ltd.	0fdded64-4e89-d28c-e063-6394a90a7b8f	2026-01-01	Warnings	Exact identifier application number: M003
OP First Aid Series Alcohol Prep Pad	ISOPROPYL ALCOHOL	Yiwu Ori-Power Medtech Co., Ltd.	b3da7cff-4555-358e-e053-2995a90ae0ff	2026-01-01	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	Astera International LLC	a5189240-19ce-7715-e053-2995a90ad043	2025-12-31	Warnings	Exact identifier application number: M003
Water Jel Hydrogen Peroxide	HYDROGEN PEROXIDE	Water-Jel Technologies	f508c3cb-e162-4d11-9513-ff44918f82c0	2025-12-31	Warnings	Exact identifier application number: M003
HEB 70 Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	HEB Grocery Company	e8dd7f84-3690-4ab3-a21f-43bf66984f4b	2025-12-30	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	HAIAN KANGRUI TEXTILE CO., LTD.	4711fb91-8afd-e5db-e063-6394a90a4b9e	2025-12-29	Warnings	Exact identifier application number: M003
Antiseptic	BENZETHONIUM CHLORIDE	MPM Medical, LLC	3f660269-f83d-4f71-9a70-e2ddb2c57ec6	2025-12-29	Warnings	Exact identifier application number: M003
SnugZ Hand Sanitizing Spry	HAND SANITIZER SPRAY	SnugZ/USA, LLC	9391bc26-57e6-daec-e053-2995a90a1eb6	2025-12-29	Warnings	Exact identifier application number: M003
SnugZ Beaded Hand Sanitizer Gel	BEADED HAND SANITIZER GEL	SnugZ/USA, LLC	6deb1142-dfba-a72b-e053-2991aa0aba43	2025-12-29	Warnings	Exact identifier application number: M003
SnugZ Hand Sanitizer Gel	HAND SANITIZER GEL	SnugZ/USA, LLC	69bc7a80-0898-4c08-e053-2a91aa0a87a9	2025-12-29	Warnings	Exact identifier application number: M003
Englewood Mesh Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	a737fe63-6285-41ee-9516-9c3030a0ab48	2025-12-29	Warnings	Exact identifier application number: M003
Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL CLOTH	JINHUA JINGDI MEDICAL SUPPLIES CO., LTD	4710c90b-ce88-b0b8-e063-6294a90a3860	2025-12-28	Warnings	Exact identifier application number: M003
Freshnap Plus - 80% Ethyl Alcohol Towelette	ALCOHOL TOWELETTE	KARI-OUT LLC	f4ae66e3-323b-5e2e-e053-2995a90acf42	2025-12-27	Warnings	Exact identifier application number: M003
Guardelle	BENZALKONIUM CHLORIDE	Social Medical Supply LLC	8793e3be-7409-4f71-9397-abbeacd27cf8	2025-12-22	Warnings	Exact identifier application number: M003
CareALL First Aid Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCL	New World Imports, Inc	69eef888-0044-485c-96a1-247ed1204858	2025-12-22	Warnings	Exact identifier application number: M003
Hand Sanitizer Pear Blossom Tea	ALCOHOL SOLUTION	Noshinku	46927edb-f8be-f0b9-e063-6294a90a8e56	2025-12-22	Warnings	Exact identifier application number: M003
Hand Sanitizer Santal Blanc	ALCOHOL SOLUTION	Noshinku	4692c807-268e-6477-e063-6394a90aac0a	2025-12-22	Warnings	Exact identifier application number: M003
Hand Sanitizer Vanilla Creme	ALCOHOL SOLUTION	Noshinku	4692e68c-2bc8-83f8-e063-6294a90a84e4	2025-12-22	Warnings	Exact identifier application number: M003
Alcohol sanitizer wipes	ALCOHOL/PURIFIED WATER	SHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.	ab9634bd-4226-2f73-e053-2995a90a802f	2025-12-19	Warnings	Exact identifier application number: M003
Sanitizing Wipes	BENZALKONIUM CHLORIDE	Wipes LLC	9e9a76d9-23e0-4d3a-9903-8bf7aba54aa3	2025-12-19	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RELEEV 1 day Cold sore Symptom Treatment	Merix Pharmaceutical Corp.	2026-02-02	HUMAN OTC DRUG LABEL	19