Salicylic Acid

Product NDC: 54295-304
11-digit product format: 542950304
Labeler code: 54295
Product ID: 54295-304_32eeeb54-937e-487a-b260-7425e5b176dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: salicylic acid
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Trinity Pharmaceuticals, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2013-11-16
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 275 mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54295-304		I	Inactivated by FDA		2026-09-14
excluded package	package	54295-304	54295-304-11	I	Inactivated by FDA		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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54295-304-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54295-304-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54295-304-11	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54295-304-11	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54295-304-11	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54295-304-11	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54295-304-11	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54295-304-11	2023-03-22	C162847	48780-1	9855e2a2-4914-60a7-e053-dbdaa90a05bd	Salicylic Acid, 27.5%
54295-304-11	2019-11-27	C162847	48780-1	9855e2a2-4914-60a7-e053-dbdaa90a05bd	Salicylic Acid, 27.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54295-304-11	Salicylic Acid	1 in 1 CARTON	SOLUTION	1		2
54295-304-11	Salicylic Acid	10 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	10		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54295-304-11	ML - Milliliter	54295-304	300cb2c4-8510-4171-b81b-7c14184425c9	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
salicylic acid	ACTIVE INGREDIENT	O414PZ4LPZ	SALICYLIC ACID SOLUTION [TRINITY PHARMACEUTICALS, LLC]	1
salicylic acid	ACTIVE MOIETY	O414PZ4LPZ	SALICYLIC ACID SOLUTION [TRINITY PHARMACEUTICALS, LLC]	1
BUTYL ACETATE	INACTIVE INGREDIENT	464P5N1905	SALICYLIC ACID SOLUTION [TRINITY PHARMACEUTICALS, LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SALICYLIC ACID SOLUTION [TRINITY PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54295-304	SALICYLIC ACID SOLUTION [TRINITY PHARMACEUTICALS, LLC]	2	Legacy NDC, 2 package rows	20230323_31c49cc7-e324-44c7-bd26-2d2344c34a40.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O414PZ4LPZ	SALICYLIC ACID	69-72-7	SALICYLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1095689	salicylic acid 27.5 % Topical Solution	PSN	31c49cc7-e324-44c7-bd26-2d2344c34a40	2
1095689	salicylic acid 275 MG/ML Topical Solution	SCD	31c49cc7-e324-44c7-bd26-2d2344c34a40	2
1095689	salicylic acid 27.5 % Topical Solution	SY	31c49cc7-e324-44c7-bd26-2d2344c34a40	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
54295-304-11	54295030411	1 in 1 CARTON	Historical