El Valle Merthiolate

Product NDC: 55758-375
11-digit product format: 557580375
Labeler code: 55758
Product ID: 55758-375_4df13d29-3a69-c83a-e063-6394a90a393f
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: Pharmadel LLC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-05-31
Substance: BENZALKONIUM CHLORIDE
Active strength: 1.3 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55758-375	55758-375-01	D	Discontinued by firm		2026-10-16

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: El Valle Merthiolate
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049254	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
fd7b28ca-9f71-0ff6-e053-6394a90a4822	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55758-375-01	El Valle Merthiolate	15 mL in 1 BOTTLE, PLASTIC	LIQUID	15		6
55758-375-02	El Valle Merthiolate	30 mL in 1 BOTTLE	LIQUID	30		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55758-375	EL VALLE MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [PHARMADEL LLC]	3	Current NDC, 2 package rows	20241120_fd7b28ca-9f71-0ff6-e053-6394a90a4822.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 14 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Antibiotic plus Burn Relief	BACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCI	Trifecta Pharmaceuticals USA LLC	048871e2-c917-292d-e063-6394a90af130	2024-12-18	Warnings	Exact identifier application number: M004
TheraCare Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Veridian Healthcare	0c3fc798-9a97-5316-e063-6394a90a6830	2024-12-18	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Rugby Laboratories	ac3c9897-c812-1360-e053-2a95a90ad591	2024-12-17	Warnings	Exact identifier application number: M004
Major Bacitracin	BACITRACIN ZINC	Major Pharmaceuticals	a23ce772-7078-0a4b-e053-2995a90aff0d	2024-12-17	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Trifecta Pharmaceuticals USA LLC	eea0d90c-914b-2624-e053-2a95a90a34c9	2024-12-13	Warnings	Exact identifier application number: M004
OP First Aid Series TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	cadebf07-dd48-4855-8296-7a91e28d7123	2024-12-05	Warnings	Exact identifier application number: M004
triple antibiotic and pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	f0864d78-23e6-4e6c-bc67-7ba3e6dd862c	2024-12-03	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Publix Super Markets Inc	330c7b7a-d0d1-42dc-b8f7-9c96aeaf69f9	2024-11-25	Warnings	Exact identifier application number: M004
WinCo Maximum Strength Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE	WinCo Foods, LLC	01b03c7e-6c4e-43aa-8480-aff1c2688f7f	2024-11-21	Warnings	Exact identifier application number: M004
WinCo Original Strength Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	WinCo Foods, LLC	e364b623-6e20-4894-8d4c-5c739be78f86	2024-11-21	Warnings	Exact identifier application number: M004
Winco Bacitracin Zinc	BACITRACIN ZINC	WinCo Foods, LLC	dcdf647f-fa32-4b72-b714-a77e8e332358	2024-11-21	Warnings	Exact identifier application number: M004
Walgreens Multi-Antibiotic with Pain Relief Cream	POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Walgreens Company	f4feccc3-ac25-4d8a-9b68-9a24f755524a	2024-11-20	Warnings	Exact identifier application number: M004
Walgreens Kids Multi-Antibiotic with Pain Relief Cream	POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Walgreens Company	fbc364d7-d8b8-43f5-99cc-290438f3982b	2024-11-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Acme United Corporation	f9a48f73-aa12-cf68-e053-6294a90a8e53	2024-11-19	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Acme United Corporation	e55cbf7e-c955-7f1a-e053-2a95a90a3f28	2024-11-19	Warnings	Exact identifier application number: M004
First Aid Only Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Acme United Corporation	f4eba34c-ce31-3004-e053-2995a90a245b	2024-11-19	Warnings	Exact identifier application number: M004
First Aid Only Neomycin Antibiotic	NEOMYCIN SULFATE	Acme United Corporation	c651e98e-aabe-de46-e053-2a95a90a6307	2024-11-19	Warnings	Exact identifier application number: M004
Neosporin Original	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Kenvue Brands LLC	f07d3bca-4312-46ed-b0c4-f886c01bd095	2024-11-14	Warnings	Exact identifier application number: M004
Polysporin First Aid Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Kenvue Brands LLC	e0fcf83e-a374-4fc0-a629-873033054392	2024-11-14	Warnings	Exact identifier application number: M004
Neosporin Pain Itch Scar	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	55392c48-b5d8-44cd-8c10-6d8668349848	2024-11-13	Warnings	Exact identifier application number: M004

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	fd7b28ca-9f71-0ff6-e053-6394a90a4822	6
1049254	benzalkonium chloride 1.3 MG/ML Topical Solution	SCD	fd7b28ca-9f71-0ff6-e053-6394a90a4822	6
1049254	benzalkonium chloride 0.13 % Topical Solution	SY	fd7b28ca-9f71-0ff6-e053-6394a90a4822	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55758-375-01	55758037501	15 mL in 1 BOTTLE, PLASTIC	15 ml				Historical
55758-375-02	55758037502	30 mL in 1 BOTTLE (55758-375-02)	30 ml	2023-05-31	No	No	Current