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 50 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEYO	DISINFECTING WET WIPES	Henan Yeesain Health Technology Co., Ltd.	b147ed5b-ab6e-ca00-e053-2a95a90ae01a	2025-12-10	Warnings	Exact identifier application number: M003
BIOCENCE	EUCALYPTOL THYMOL	Bio-Germ Protection LLC	1ea56ac9-4fc2-41c0-adda-5a2c55bef696	2025-12-10	Warnings	Exact identifier application number: M003
BIOCENCE	EUCALYPTOL THYMOL	Bio-Germ Protection LLC	847b9edc-74e6-43fd-83cd-43e6712780c6	2025-12-10	Warnings	Exact identifier application number: M003
The Pharma-C Company 70 Isopropyl Alcohol Pads	ISOPROPYL ALCOHOL	Kleen Test Products Corporation	c5df867b-1b8d-4e38-8c32-7d528b982590	2025-12-09	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	bf399508-bd29-0d90-e053-2995a90a067f	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dceb351a-06fb-8222-e053-2a95a90aadbf	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dcead234-bb98-1ee8-e053-2a95a90a3186	2025-12-06	Warnings	Exact identifier application number: M003
75% Alcohol Disinfectant	ALCOHOL	Zhejiang Meimi Technology Co., Ltd.	acfdfa78-69e7-27dc-e053-2a95a90a8548	2025-12-06	Warnings	Exact identifier application number: M003
75% Alcohol Disinfectant	ALCOHOL	Zhejiang Meimi Technology Co., Ltd.	ad0cdcf1-7d8b-dcc9-e053-2995a90a4b4b	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dceb9358-663c-3c70-e053-2995a90a3524	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dced08e7-a0bc-1328-e053-2995a90afb26	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dcec13da-586c-6e7e-e053-2a95a90a6cd1	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dceced03-eeb8-fced-e053-2995a90afd5c	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dced643b-96fb-193f-e053-2a95a90a16aa	2025-12-06	Warnings	Exact identifier application number: M003
Betadine Foam Cleanser	BENZALKONIUM CHLORIDE	Atlantis Consumer Healthcare, Inc.	3be9fa6e-3ae8-496b-876b-f81f1cd98af4	2025-12-05	Warnings	Exact identifier application number: M003
2XL Mega Rolls Sanitizing Wipes	BENZALKONIUM CHLORIDE	2xl Corporation	9da541ab-6836-4149-a86d-3b2f2e586628	2025-12-05	Warnings	Exact identifier application number: M003
Hand Wipes	BENZALKONIUM CHLORIDE	Advanced Ultrasound Solutions Inc.	2c2abaa8-c152-470b-a4d9-5056815a1987	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	SANITIZING HAND WIPES	ALO NEW YORK LLC	d3d95355-3af7-43e3-e053-2a95a90a0fa4	2025-12-05	Warnings	Exact identifier application number: M003
Giant Eagle Antibacterial Hand Wipes	BENZALKONIUM CHLORIDE	Giant Eagle	e20e9a93-03c3-77f8-e053-2995a90ae59f	2025-12-05	Warnings	Exact identifier application number: M003
Antibacterial Wipes	BENZALKONIUM CHLORIDE	ERC Acquisition, Inc	dc6c39af-447c-481a-98b5-33b8f09b83bc	2025-12-05	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