LEROSETT High-Content Organic Acne Treatment

Product NDC: 58133-062
11-digit product format: 581330062
Labeler code: 58133
Product ID: 58133-062_ff70bbb4-b434-483f-a510-3b811a1b331b
Type: HUMAN OTC DRUG
Nonproprietary name: Salicylic Acid
Dosage form: GEL
Route: TOPICAL
Labeler: Cosmetic Specialty labs, Inc.
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-01-01
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 2 g/100mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58133-062		I	Inactivated by FDA	2026-10-16
excluded package	package	58133-062	58133-062-13	I	Inactivated by FDA	2026-10-16
excluded package	package	58133-062	58133-062-67	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 2 · 63 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	58133-062-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58133-062-67	`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	58133-062-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58133-062-67	`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	58133-062-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58133-062-67	`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	58133-062-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58133-062-67	`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	58133-062-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58133-062-67	`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	58133-062-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58133-062-67	`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	58133-062-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58133-062-67	`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	58133-062-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58133-062-67	`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	58133-062-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58133-062-67	`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	58133-062-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58133-062-67	`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	58133-062-13	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58133-062-67	`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	58133-062-13	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58133-062-67	`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	58133-062-13	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58133-062-67	`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	58133-062-13	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58133-062-67	`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	58133-062-13	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58133-062-67	`1332a3947898…`	`d4bfe170f9cd…`
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	58133-062-13	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58133-062-67	`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	58133-062-13	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58133-062-67	`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	58133-062-13	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58133-062-67	`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	58133-062-13	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58133-062-67	`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	58133-062-13	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58133-062-67	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58133-062-13	2020-01-31	C162847	48780-1	9d75b9d0-2fa1-f424-e053-dadaa90a57ce	10e91140-652c-4275-8f38-dedd29786e8e
58133-062-67	2020-01-31	C162847	48780-1	9d75b9d0-2fa1-f424-e053-dadaa90a57ce	10e91140-652c-4275-8f38-dedd29786e8e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58133-062-13	LEROSETT High-Content Organic Acne TreatmentBotanically Based	385 mL in 1 BOTTLE	GEL	385		1
58133-062-67	LEROSETT High-Content Organic Acne TreatmentBotanically Based	200 mL in 1 BOTTLE	GEL	200		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
COCO GLUCOSIDE	INACTIVE INGREDIENT	ICS790225B	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
GLYCERYL OLEATE	INACTIVE INGREDIENT	4PC054V79P	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
LAURIC DIETHANOLAMIDE	INACTIVE INGREDIENT	I29I2VHG38	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
LAURYL GLUCOSIDE	INACTIVE INGREDIENT	76LN7P7UCU	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
SODIUM LAURYL GLYCOL CARBOXYLATE	INACTIVE INGREDIENT	8L0472VMYL	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58133-062	LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]	1	Legacy NDC, 2 package rows	20130515_10e91140-652c-4275-8f38-dedd29786e8e.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
1423838	LEROSETT 2 % Medicated Liquid Soap	PSN	10e91140-652c-4275-8f38-dedd29786e8e	1
562600	salicylic acid 2 % Medicated Liquid Soap	PSN	10e91140-652c-4275-8f38-dedd29786e8e	1
1423838	salicylic acid 20 MG/ML Medicated Liquid Soap [LEROSETT]	SBD	10e91140-652c-4275-8f38-dedd29786e8e	1
562600	salicylic acid 20 MG/ML Medicated Liquid Soap	SCD	10e91140-652c-4275-8f38-dedd29786e8e	1
1423838	LEROSETT 2 % Medicated Liquid Soap	SY	10e91140-652c-4275-8f38-dedd29786e8e	1
1423838	LEROSETT 20 MG/ML Medicated Liquid Soap	SY	10e91140-652c-4275-8f38-dedd29786e8e	1
562600	salicylic acid 2 % Facial Cleanser Toner	SY	10e91140-652c-4275-8f38-dedd29786e8e	1
562600	salicylic acid 2 % Facial Scrub	SY	10e91140-652c-4275-8f38-dedd29786e8e	1
562600	salicylic acid 2 % Medicated Liquid Soap	SY	10e91140-652c-4275-8f38-dedd29786e8e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
58133-062-13	58133006213	385 mL in 1 BOTTLE	385 ml	Historical
58133-062-67	58133006267	200 mL in 1 BOTTLE	200 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Salicylic Acid - Cosmetic Specialty labs, Inc.	Cosmetic Specialty labs, Inc.	2013-01-24	HUMAN OTC DRUG LABEL	1