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 22 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lucys Renewals Skin and Nails First Aid Antiseptic	BENZETHONIUM CHLORIDE	ACP Laboratories LLC	a702297d-8f7e-4019-a987-7bd83becb5ee	2026-05-07	Warnings	Exact identifier application number: M003
Scentfull Hand Sanitizer Sea Breeze	ALCOHOL	Scent Theory Products LLC	3cfac192-84c8-7897-e063-6294a90ae93d	2026-05-06	Warnings	Exact identifier application number: M003
Scentfull Hand Sanitizer Whipped Coconut	ALCOHOL	Scent Theory Products LLC	3cfaadb3-1881-2dd9-e063-6394a90abcb4	2026-05-06	Warnings	Exact identifier application number: M003
Scentfull Hand Sanitizer Pink Champagne	ALCOHOL	Scent Theory Products LLC	3cf7a910-28c8-bbe2-e063-6394a90aff73	2026-05-06	Warnings	Exact identifier application number: M003
Kleenex Reveal Moisturizing Foam Hand Sanitizer	ALCOHOL	Kimberly-Clark	4a491f90-268e-470d-a74c-473f1efe7c8b	2026-05-06	Warnings	Exact identifier application number: M003
Boo Crew Hand Care Essentials Boo Berry, Pumpkin Spice	ALCOHOL	Scent Theory Products LLC	51143d5c-4cd0-0b2e-e063-6294a90a2831	2026-05-05	Warnings	Exact identifier application number: M003
Scott Moisturizing Foam Hand Sanitizer	ALCOHOL	Kimberly-Clark	25900e62-c8fd-4942-ad38-4b9924308460	2026-05-05	Warnings	Exact identifier application number: M003
EVERLIT CARE PRODUCTS ANTISEPTIC MIST	HYDROGEN PEROXIDE	Nantong Health & Beyond Hygienic Products Inc.	cb97ba55-d678-4e43-aa85-37e9f530e911	2026-05-04	Warnings	Exact identifier application number: M003
EVERLIT CARE PRODUCTS ANTISEPTIC MIST	HYDROGEN PEROXIDE	EVERLIT GLOBAL INC.	4873b106-4ea2-412c-a7ab-756a11195984	2026-05-04	Warnings	Exact identifier application number: M003
Limited Edition Hand Sanitizer Golden Vanilla, Starlight Frost, Pink Satin Prosecco	ALCOHOL	Scent Theory Products LLC	50f03829-eda8-3a25-e063-6294a90a6fd2	2026-05-03	Warnings	Exact identifier application number: M003
DUBBLE BUBBLE HAND SANITIZER BUBBLE GUM	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	52084e0a-ffe2-83f4-e063-6294a90a305e	2026-05-01	Warnings	Exact identifier application number: M003
DIPPIN DOTS HAND SANI BIRTHDAY CAKE	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	520828a5-4e8d-b637-e063-6394a90ab491	2026-05-01	Warnings	Exact identifier application number: M003
ICEE HAND SANI BLUE RASBERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	52089622-d9b5-b5cb-e063-6394a90ad426	2026-05-01	Warnings	Exact identifier application number: M003
DIPPIN DOTS HAND SANITIZER COTTON CANDY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5208adea-27da-81a3-e063-6294a90afc80	2026-05-01	Warnings	Exact identifier application number: M003
ICEE HAND SANI CHERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	52089622-d9b6-b5cb-e063-6394a90ad426	2026-05-01	Warnings	Exact identifier application number: M003
KOOL AID HAND SANITIZER BUBBLE PINK LEMONADE	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5208bd2c-277c-648e-e063-6294a90a5b28	2026-05-01	Warnings	Exact identifier application number: M003
DIPPIN DOTS HAND SANITIZER RAINBOW ICE	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	52092127-7a8d-5db3-e063-6294a90a07b5	2026-05-01	Warnings	Exact identifier application number: M003
Liquid death hand sanitizer	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	520943a4-0e63-a9ab-e063-6394a90ab2a9	2026-05-01	Warnings	Exact identifier application number: M003
Redicare Antiseptic Towelettes	ANTISEPTIC TOWELETTES	Redicare LLC	484c8ff5-cc11-b646-e063-6394a90a5f50	2026-05-01	Warnings	Exact identifier application number: M003
Redicare Alcohol Prep Pads	MEDIUM ALCOHOL PREP PADS	Redicare LLC	3cb7fba1-1d2d-f4da-e063-6394a90a4b21	2026-05-01	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