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 16 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACITRACIN	BACITRACIN	Meijer Distribution Inc	029e7150-1b9a-47c9-90bd-5f8bcd21365c	2024-10-29	Warnings	Exact identifier application number: M004
SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	A-S Medication Solutions	01131ba6-6d5b-4710-bec3-ba1769c08c79	2024-10-22	Warnings	Exact identifier application number: M004
BACITRACIN	BACITRACIN	CVS Pharmacy	15ea4415-943a-4d0a-ac23-5f37cd2cf206	2024-10-22	Warnings	Exact identifier application number: M004
Tetracyte First Aid and Antibiotic Topical	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	dcb3d96a-41a5-40d8-a47e-56d419bbe6e2	2024-10-21	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	CVS Pharmacy	3ba24e32-7078-45fb-85d1-2ab252fa9cb5	2024-10-16	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Meijer Distribution Inc	43486da5-6e8b-45c0-bd7e-cc2d8b28c510	2024-10-16	Warnings	Exact identifier application number: M004
Genuine First Aid First Aid Antibiotic Bacitracin Zinc	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production (Xiamen) Co., Ltd.	af08c1fe-fb1a-56d2-e053-2a95a90a67c4	2024-10-15	Warnings	Exact identifier application number: M004
Exchange Select First Aid Triple Anitbiotic Pain Relieving	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Army & Air Force Exchange Service	1c7f1700-69c0-4a71-8bb0-a71e3082efeb	2024-10-14	Warnings	Exact identifier application number: M004
antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	H E B	55fa94cb-7e1c-41bc-879a-5618a828f14a	2024-10-14	Warnings	Exact identifier application number: M004
first aid antibiotic and pain relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Meijer, Inc.	f0892a30-8a88-44e8-ab04-0e87c12f9c44	2024-10-14	Warnings	Exact identifier application number: M004
triple antibiotic plus pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Meijer Distribution Inc	d97a69e8-4058-4c77-b628-ad3e2b97a620	2024-10-14	Warnings	Exact identifier application number: M004
Antibiotic and Pain Relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	b541f1a9-7e40-4c35-840f-ea1e357b580e	2024-10-14	Warnings	Exact identifier application number: M004
Exchange Select triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Army & Air Force Exchange Service	b7bf899c-44e5-48d6-bf8e-d843fd442432	2024-10-12	Warnings	Exact identifier application number: M004
topcare triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Topco Associates LLC	675665ee-bd0d-4168-81b8-341b1258c102	2024-10-12	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Hubei Changjian Medical Products Co., Ltd.	34e8776c-1f36-4e1b-9d71-727591ac904d	2024-10-11	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	H E B	58a4d263-e234-43cd-a3bd-b19a492174d9	2024-10-11	Warnings	Exact identifier application number: M004
topcare triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	5e0fc39b-e6d4-4543-8afc-2881e2f85f9b	2024-10-06	Warnings	Exact identifier application number: M004
Good Sense Triple Antibiotic and Pain Relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	L. Perrigo Company	c3e9215f-fcef-4938-8208-df4099652289	2024-10-06	Warnings	Exact identifier application number: M004
triple antibiotic plus maximum strength	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	H E B	c428b0a3-e80a-493c-ac67-807ebca3ce01	2024-10-06	Warnings	Exact identifier application number: M004
Basic Care First Aid Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Amazon.com Services LLC	a9247f69-0366-42dd-ae0d-39a2a6976cdc	2024-10-06	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