Ultrasal-ER

Product NDC: 42783-323
11-digit product format: 427830323
Labeler code: 42783
Product ID: 42783-323_eb087bbb-fd4d-4a5e-bd39-057ddf32ed86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: salicylic acid
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Elorac, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2014-01-30
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 285 mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	42783-323		I	Inactivated by FDA		2026-10-16
excluded package	package	42783-323	42783-323-10	I	Inactivated by FDA		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 · 30 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42783-323-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42783-323-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42783-323-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42783-323-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42783-323-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42783-323-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42783-323-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42783-323-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42783-323-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42783-323-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42783-323-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42783-323-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42783-323-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42783-323-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42783-323-10	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42783-323-10	2023-01-30	C162847	48780-1	f386c649-cdec-0266-e053-dadaa90a7c1a	a01a3ccd-d9bc-40b6-b269-cddd6d0e47c5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42783-323-10	Ultrasal-ER	10 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	10		25
42783-323-10	Ultrasal-ER	1 in 1 CARTON	SOLUTION	1		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42783-323-10	ML - Milliliter	42783-323	2369453e-1506-4e07-8bd3-19fdc0e5929d	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
salicylic acid	ACTIVE INGREDIENT	O414PZ4LPZ	ULTRASAL-ER (SALICYLIC ACID) SOLUTION [ELORAC, INC.]	2
salicylic acid	ACTIVE MOIETY	O414PZ4LPZ	ULTRASAL-ER (SALICYLIC ACID) SOLUTION [ELORAC, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42783-323	ULTRASAL-ER (SALICYLIC ACID) SOLUTION [ELORAC, INC.]	25	Legacy NDC, 2 package rows	20211209_a01a3ccd-d9bc-40b6-b269-cddd6d0e47c5.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
1487371	salicylic acid 28.5 % Topical Solution	PSN	a01a3ccd-d9bc-40b6-b269-cddd6d0e47c5	25
1487376	UltraSal-ER 28.5 % Wart Remover Topical Solution	PSN	a01a3ccd-d9bc-40b6-b269-cddd6d0e47c5	25
1487376	salicylic acid 285 MG/ML Topical Solution [Ultrasal]	SBD	a01a3ccd-d9bc-40b6-b269-cddd6d0e47c5	25
1487371	salicylic acid 285 MG/ML Topical Solution	SCD	a01a3ccd-d9bc-40b6-b269-cddd6d0e47c5	25
1487371	salicylic acid 28.5 % Topical Solution	SY	a01a3ccd-d9bc-40b6-b269-cddd6d0e47c5	25
1487376	Ultrasal 285 MG/ML Topical Solution	SY	a01a3ccd-d9bc-40b6-b269-cddd6d0e47c5	25
1487376	Ultrasal-ER 28.5 % Film-Forming Topical Solution	SY	a01a3ccd-d9bc-40b6-b269-cddd6d0e47c5	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42783-323-10	42783032310	1 BOTTLE, WITH APPLICATOR in 1 CARTON (42783-323-10) > 10 mL in 1 BOTTLE, WITH APPLICATOR	2014-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ultrasal-ER - Elorac, Inc. \| Swiss-American CDMO, LLC \| Microconsult, Inc.	Elorac, Inc. \| Swiss-American CDMO, LLC \| Microconsult, Inc.	2021-12-08	HUMAN PRESCRIPTION DRUG LABEL	25