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		2026-09-14

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…`

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 1 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	NuCare Pharmaceutical, Inc.	5b14499e-e45c-7c05-e063-6294a90a1cc2	2026-09-09	Warnings	Exact identifier application number: M004
American Safety and First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	eb0df2da-1688-c477-e053-2995a90a74a2	2026-09-07	Warnings	Exact identifier application number: M004
American Safety and First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	eb0d108f-42bf-3364-e053-2a95a90a4542	2026-09-07	Warnings	Exact identifier application number: M004
MEDI-FIRST	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	f4e4d0a4-b90c-99b0-e053-2995a90ab423	2026-09-04	Warnings	Exact identifier application number: M004
Lil Drug Store Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	ORAZEN INC	e6e5263b-328f-4775-9fac-34302f050ce0	2026-09-04	Warnings	Exact identifier application number: M004
MEDI-FIRST	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	f4e42c5c-e080-4efb-e053-2a95a90af52e	2026-09-04	Warnings	Exact identifier application number: M004
MEDI-FIRST	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	f4e4854a-ee01-df72-e053-2995a90aa8ea	2026-09-04	Warnings	Exact identifier application number: M004
Circle K Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	ORAZEN INC	84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a	2026-09-04	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Walgreen Company	b982091a-5aa0-4bbc-bb1d-08016f6d0a70	2026-09-03	Warnings	Exact identifier application number: M004
SurviveX Triple Antibiotic	TRIPLE ANTIBIOTIC	Nantong Health & Beyond Hygienic Products Inc.	5a7cb52d-a60c-b947-e063-6394a90afb0d	2026-09-02	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Walgreen Company	4f3cfe39-2df8-48b4-954d-5997217c92ba	2026-08-31	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	217aa2b8-94f5-468a-99b4-52824a77b573	2026-08-28	Warnings	Exact identifier application number: M004
OP Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Yiwu Ori-Power Medtech Co., Ltd.	03f3cce9-7e9f-90a6-e063-6294a90a660b	2026-08-28	Warnings	Exact identifier application number: M004
Alcare Extra Hand Sanitizer	ALCOHOL	SC Johnson Professional USA Inc.	5dc007a2-61fa-4115-a82c-1aa489a6bd39	2026-08-27	Warnings	Exact identifier application number: M004
InstantFoam Complete PURE	ALCOHOL	SC Johnson Professional USA Inc.	398ca23c-7202-4670-be14-9829675f7174	2026-08-27	Warnings	Exact identifier application number: M004
Be Smart Get Prepared Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Total Resources International, Inc	57ed1a03-7e1b-4eb4-8001-dfd118805edc	2026-08-24	Warnings	Exact identifier application number: M004
Claravie	BACITRACIN ZINC	Gentell LLC	59c5a363-6d79-d07e-e063-6294a90a8753	2026-08-24	Warnings	Exact identifier application number: M004
Claravie	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B	Gentell LLC	597cb2f0-ff05-a1ab-e063-6294a90acda9	2026-08-20	Warnings	Exact identifier application number: M004
Medpride First Aid	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Shield Line LLC	5ba3e703-7873-4724-a0bf-bb22d8a25748	2026-08-18	Warnings	Exact identifier application number: M004
Medpride First Aid	BACITRACIN ZINC	Shield Line LLC	e6a6fb0f-5ab7-4647-84a0-7b9948eed303	2026-08-18	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