Salicylic Acid

Product NDC: 42546-270
11-digit product format: 425460270
Labeler code: 42546
Product ID: 42546-270_3ee9ee78-76b5-450c-9211-4c0574b9959e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Salicylic Acid
Dosage form: KIT
Labeler: PruGen, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-05-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
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	42546-270		I	Inactivated by FDA		2026-10-15
excluded package	package	42546-270	42546-270-01	I	Inactivated by FDA		2026-10-15

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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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	42546-270-01	`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
42546-270-01	2024-01-30	C162847	48780-1	1030e365-6a4a-111a-e063-dadaa90a10e2	Salicylic Acid 6% Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42546-270-01	Salicylic Acid	1 in 1 BOX	KIT	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42546-270-01	EA - Each	42546-270	6d9c0c93-fb9e-4941-9fd4-51d113b43179	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
AMMONIUM LACTATE	INACTIVE INGREDIENT	67M901L9NQ	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
DIMETHICONE 350	INACTIVE INGREDIENT	2Y53S6ATLU	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
GLYCERYL STEARATE SE	INACTIVE INGREDIENT	FCZ5MH785I	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATE	INACTIVE INGREDIENT	395MHJ5PUR	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	SALICYLIC ACID CREAM [PRUGEN, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SALICYLIC ACID CREAM [PRUGEN, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42546-270	SALICYLIC ACID KIT [PRUGEN, INC.]	7	Legacy NDC, 1 package rows	20220122_99d7e2ad-2dc3-4177-80eb-137715855b8a.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
477031	salicylic acid 6 % Topical Cream	PSN	99d7e2ad-2dc3-4177-80eb-137715855b8a	7
477031	salicylic acid 60 MG/ML Topical Cream	SCD	99d7e2ad-2dc3-4177-80eb-137715855b8a	7
477031	salicylic acid 6 % Topical Cream	SY	99d7e2ad-2dc3-4177-80eb-137715855b8a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42546-270-01	42546027001	1 KIT in 1 BOX (42546-270-01) * 454 g in 1 JAR * 355 g in 1 BOTTLE	1 kit	2011-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Salicylic Acid 6% Cream	PruGen, Inc. \| DERMAZONE SOLUTIONS, INC.	2022-01-19	HUMAN PRESCRIPTION DRUG LABEL	7