El Valle Gentian Violet

Product NDC: 55758-373
11-digit product format: 557580373
Labeler code: 55758
Product ID: 55758-373_4f5ea8bd-610f-3a7f-e063-6394a90af8dd
Type: HUMAN OTC DRUG
Nonproprietary name: Gentian Violet 1%
Dosage form: LIQUID
Route: TOPICAL
Labeler: Pharmadel LLC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-05-31
Substance: GENTIAN VIOLET
Active strength: 10 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	55758-373	55758-373-02	D	Discontinued by firm		2026-10-21

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 Gentian Violet
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GENTIAN VIOLET	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J4Z741D6O5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310481	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
fc75aa2b-0e6e-e2f7-e053-6294a90ac01f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55758-373-01	El Valle Gentian Violet	30 mL in 1 BOTTLE, PLASTIC	LIQUID	30		7
55758-373-02	El Valle Gentian Violet	15 mL in 1 BOTTLE, PLASTIC	LIQUID	15		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55758-373	EL VALLE GENTIAN VIOLET (GENTIAN VIOLET 1%) LIQUID [PHARMADEL LLC]	5	Current NDC, 2 package rows	20241120_fc75aa2b-0e6e-e2f7-e053-6294a90ac01f.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 4 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lynx LX0864 peachy-foam antiseptic handsoap	CHLOROXYLENOL	ABC Compounding Co., Inc.	dd8025cb-d160-83a4-e053-2a95a90a51ac	2026-05-11	Warnings	Exact identifier application number: M004
Satin Foam High Foaming Antiseptic Hand Wash	CHLOROXYLENOL	Certus Medical, Inc.	ea49da65-ae5e-bfde-e053-2a95a90adef2	2026-05-11	Warnings	Exact identifier application number: M004
Freshands Premium Foamy Antibacterial Handsoap 6876	CHLOROXYLENOL	Consolidated Chemicals, LLC	f17299a4-28d6-e65b-e053-2a95a90a05e7	2026-05-11	Warnings	Exact identifier application number: M004
Harris Teeter Triple Antibiotic and Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCL	HARRIS TEETER LLC	4b0c0a3c-7145-97ca-e063-6394a90a1a96	2026-05-07	Warnings	Exact identifier application number: M004
Harris Teeter Triple Antibiotic	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC	HARRIS TEETER LLC	4e81590c-32d3-f8aa-e063-6294a90ab341	2026-05-06	Warnings	Exact identifier application number: M004
FIRSTAR TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	5b9434ad-83d7-4df3-bfef-3db152e6c6cc	2026-05-04	Warnings	Exact identifier application number: M004
oopsie First Aid	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	4 Visions LLC	50b21f0a-1e87-51ae-e063-6294a90a8a3c	2026-04-30	Warnings	Exact identifier application number: M004
First Aid Kit, Lil Drug Store	5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS	Lil' Drug Store Products, Inc.	503c6c0e-3e1a-71ed-e063-6394a90abfa2	2026-04-24	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	TRIFECTA PHARMACEUTICALS USA LLC	23a35ba8-ebc6-4252-bb88-ec237425056c	2026-04-15	Warnings	Exact identifier application number: M004
El Valle Gentian Violet	GENTIAN VIOLET 1%	Pharmadel LLC	fc75aa2b-0e6e-e2f7-e053-6294a90ac01f	2026-04-13	Warnings	Exact identifier application number: M004 ndc (product): 55758-373
Bacitracin Zinc	BACITRACIN ZINC	Sun Pharmaceutical Industries, Inc.	4afdeedf-9cdf-47d6-919f-ea907fda0290	2026-04-10	Warnings	Exact identifier application number: M004
Family Care Triple Antibiotic Original Formula 0.33oz	TRIPLE ANTIBIOTIC ORIGINAL FORMULA	United Exchange Corp	4f1ef127-a67e-ca60-e063-6394a90a3a3d	2026-04-10	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	H E B	2a143950-13b4-457e-91a4-c61a88aad84b	2026-04-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	ProStat First Aid, LLC.	4e54f479-ad87-e86b-e063-6394a90aa6d2	2026-03-31	Warnings	Exact identifier application number: M004
El Valle Merthiolate	BENZALKONIUM CHLORIDE	Pharmadel LLC	fd7b28ca-9f71-0ff6-e053-6394a90a4822	2026-03-26	Warnings	Exact identifier application number: M004
sojo Triple Antibiotic	TRIPLE ANTIBIOTIC	Jiangxi Yudexi Pharmaceutical Co., LTD	4d8429bd-24b9-ad3c-e063-6294a90aeba0	2026-03-21	Warnings	Exact identifier application number: M004
Neosporin Plus Pain Relief Clubtray	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	f4545718-8643-a340-e053-2995a90a0079	2026-03-18	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Preferred Pharmaceuticals Inc.	2f115e22-10f5-47fe-85df-f59e4387a373	2026-03-16	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	ProStat First Aid, LLC.	4cd49c65-e347-7589-e063-6394a90a53bd	2026-03-12	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	ProStat First Aid, LLC.	4cc6d822-f383-2ceb-e063-6294a90aecc7	2026-03-11	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J4Z741D6O5	GENTIAN VIOLET	548-62-9	GENTIAN VIOLET

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310481	gentian violet 1 % Topical Solution	PSN	fc75aa2b-0e6e-e2f7-e053-6294a90ac01f	7
310481	gentian violet 10 MG/ML Topical Solution	SCD	fc75aa2b-0e6e-e2f7-e053-6294a90ac01f	7
310481	gentian violet 1 % Topical Solution	SY	fc75aa2b-0e6e-e2f7-e053-6294a90ac01f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55758-373-01	55758037301	30 mL in 1 BOTTLE, PLASTIC (55758-373-01)	30 ml	2023-05-31	No	No	Current
55758-373-02	55758037302	15 mL in 1 BOTTLE, PLASTIC	15 ml				Historical