CLARIFYING PRESSED POWDER

Product NDC: 76354-201
11-digit product format: 763540201
Labeler code: 76354
Product ID: 76354-201_fdba8c12-9186-4605-9cbc-216a4a1f176f
Type: HUMAN OTC DRUG
Nonproprietary name: SALICYLIC ACID
Dosage form: POWDER
Route: TOPICAL
Labeler: J. A. Cosmetics U.S. INC
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-10-10
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 1 g/100g
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	76354-201		I	Inactivated by FDA		2026-10-21
excluded package	package	76354-201	76354-201-51	I	Inactivated by FDA		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 · 44 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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`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	76354-201-51	`110d247fa046…`	`a55b01930146…`

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
76354-201-51	2019-11-27	C162847	48780-1	9855e2a2-4809-60a7-e053-dbdaa90a05bd	a75a4012-2c6c-4bc1-95f0-ec5713314762

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76354-201-11	CLARIFYING PRESSED POWDER	30 g in 1 TUBE	POWDER	30		3
76354-201-51	CLARIFYING PRESSED POWDER	1 in 1 BOX	POWDER	1		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
MICA	INACTIVE INGREDIENT	V8A1AW0880	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
POLYBUTENE (1400 MW)	INACTIVE INGREDIENT	1NA5AO9GH7	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
SODIUM DEHYDROACETATE	INACTIVE INGREDIENT	8W46YN971G	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76354-201	CLARIFYING PRESSED POWDER (SALICYLIC ACID) POWDER [J. A. COSMETICS U.S. INC]	3	Legacy NDC, 2 package rows	20140320_a75a4012-2c6c-4bc1-95f0-ec5713314762.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
1191691	salicylic acid 1 % Topical Powder	PSN	a75a4012-2c6c-4bc1-95f0-ec5713314762	3
1191691	salicylic acid 0.01 MG/MG Topical Powder	SCD	a75a4012-2c6c-4bc1-95f0-ec5713314762	3
1191691	salicylic acid 1 % Topical Powder	SY	a75a4012-2c6c-4bc1-95f0-ec5713314762	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
76354-201-11	76354020111	30 g in 1 TUBE	30 g	Historical
76354-201-51	76354020151	1 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLARIFYING PRESSED POWDER	J. A. Cosmetics U.S. INC \| Shanghai J. A. Cosmetics Trading CO., LTD.	2014-03-19	HUMAN OTC DRUG LABEL	3