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 35 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Publix Super Markets, Inc.	14aecc7b-c68a-4cb9-863f-475e204f66a5	2026-02-05	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Publix Super Markets, Inc.	250d12ba-524e-4283-ad98-b7318f414ee0	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Publix Super Markets, Inc.	b3b5324b-ee2c-4f87-9bb9-81d3d85f73ee	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer 8 oz. Vitamin E 70 v/v	ETHYL ALCOHOL	Ningbo Rejoice International	a26a6f97-7166-0a40-e053-2a95a90a4b68	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Vitamin E and Aloe Vera	ETHYL ALCOHOL	Ningbo Rejoice International	a26a4676-6eae-088a-e053-2a95a90a7c1a	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl alcohol 50 percent	ISOPROPYL ALCOHOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	b1b52183-3296-48b2-b3d3-821c141b0bea	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl alcohol 50 percent	ISOPROPYL ALCOHOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	ee67fb96-fa2c-4542-8fdb-f2ccd885ee53	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Dyad Medical Sourcing, LLC	b5c9e222-10eb-4cea-af70-213a77fcc865	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	GoBrands, Inc.	0fb3db50-4132-07dc-e063-6294a90a8168	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	GoBrands, Inc.	0fa3615b-4181-1bd8-e063-6294a90ad129	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Greenbrier International, Inc	ce4e301b-af91-4fa0-a64c-4b235a5ff07d	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Terramed Just Think Comfort Armor Antibacterial Cleansing Bar	BENZALKONIUM CHLORIDE	Rida LLC	68e59a77-6a0c-42e2-a6a9-1353470d2e08	2026-02-04	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Grocery Outlet, Inc.	3dff8c83-7c33-7bca-e063-6394a90a675f	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Grocery Outlet, Inc.	3dffba95-71c4-a2b0-e063-6394a90aaeb3	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Grocery Outlet, Inc.	3dffcbdb-f9cd-bfdd-e063-6394a90a35a4	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	HARRIS TEETER	a90eba84-fc0f-48d7-b94e-1507f981800d	2026-02-04	Warnings	Exact identifier application number: M003
91% ISOPROPYL ALCOHOL	91% ISOPROPYL ALCOHOL	Hy-Vee, Inc.	497471bb-541c-f945-e063-6294a90adbb2	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Hy-Vee, Inc.	48316d8f-595b-7087-e063-6294a90a29ce	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL RUBBING ALCOHOL	Hy-Vee, Inc.	4831eecf-d111-6f17-e063-6394a90a4ab9	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
RoyceDerm Antibacterial Body Wash	BENZALKONIUM CHLORIDE 0.13%	RoyceDerm LLC	4a0c66b1-5a6f-b9b9-e063-6294a90a3d77	2026-02-04	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