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 36 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Smart Care Hand Sanitizer Sweet Pea Garden	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	49e7ce12-78a6-f86c-e063-6394a90a79e6	2026-02-03	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Jasmine Jewel	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	49e891ac-fa83-f687-e063-6294a90a5255	2026-02-03	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Rosebud	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	49e8bca0-e872-2585-e063-6294a90a34b2	2026-02-03	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	CVS Pharmacy, Inc.	5e3efd36-f11e-4e50-8936-fc54e67eebe5	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	CVS Pharmacy, Inc.	fbd9086c-39b2-449c-a06d-b85ec7d2dc72	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ETHYL ALCOHOL	CVS Pharmacy, Inc.	b4238c3a-f6bc-4232-932e-bece53995566	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M003
Latalia Alcohol Antiseptic 80% Sanitizing	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD	2da50235-5d89-4774-9c92-bb22cee081f1	2026-02-03	Warnings	Exact identifier application number: M003
Latalia alcohol disinfectant wipes	ETHYL ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD	4ef3c800-1754-4d9c-81d6-5309db7b04cf	2026-02-03	Warnings	Exact identifier application number: M003
Escudo Ultra-Protect Original	BENZALKONIUM CHLORIDE	Indelpa, Inc	1cd4c38f-8156-bd74-e063-6394a90a9f56	2026-02-03	Warnings	Exact identifier application number: M003
Escudo Ultra-Protect Soft Care	BENZALKONIUM CHLORIDE	Indelpa, Inc.	1cc4b68b-dceb-3fab-e063-6294a90ab112	2026-02-03	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Morning Dew	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	49f60996-6a03-77e0-e063-6394a90a7a11	2026-02-03	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Wild Cherry Blossom	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	49f64148-5c63-0107-e063-6294a90a0c45	2026-02-03	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Citrus Sunset	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	49f67a60-a6d8-0aa4-e063-6394a90a9859	2026-02-03	Warnings	Exact identifier application number: M003
WIPES4HEALTH	BENZALKONIUM CHLORIDE	Bubble Marketing LLC	5d6dd15b-d087-4f25-bd2b-035ecacd5f97	2026-02-03	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Concordance Healthcare Solutions, LLC	1c051d6a-61a8-4a75-aeb6-7c1258bda2b2	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M003
Dealmed Sterile Alcohol Prep Pads Large	ISOPROPYL ALCOHOL	Dealmed Medical Supplies, LLC.	75908e89-abd9-4760-bd11-fb71133ae2c0	2026-02-02	Warnings	Exact identifier application number: M003
Dealmed Sterile Alcohol Prep Pads Medium	ISOPROPYL ALCOHOL	Dealmed Medical Supplies, LLC.	0cdfc6b4-7d66-4333-b38d-c465d4864b5c	2026-02-02	Warnings	Exact identifier application number: M003
Medline	POVIDONE-IODINE	Medline Industries, LP	494d7e97-a3a8-2c7a-e063-6394a90a3ae1	2026-02-02	Warnings	Exact identifier application number: M003
Aplicare	ISOPROPYL ALCOHOL	Aplicare Products, LLC	4950e07f-36a5-b6f5-e063-6294a90a8f98	2026-02-02	Warnings	Exact identifier application number: M003
RELEEV Cold Sore Treatment	BENZALKONIUM CHLORIDE	Merix Pharmaceutical Corp.	fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf	2026-02-02	Warnings	Exact identifier application number: M003 ndc (package): 63287-419-01 ndc (product): 63287-419 ndc11 (package): 63287041901

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