salicylic gel

Product NDC: 53634-153
11-digit product format: 536340153
Labeler code: 53634
Product ID: 53634-153_ee2acdf0-e5dd-9691-e053-2995a90ab49e
Type: HUMAN OTC DRUG
Nonproprietary name: Salicylic Acid
Dosage form: GEL
Route: TOPICAL
Labeler: Malin and Goetz Inc
Application: M006
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-11-23
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 2 g/100mL
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	53634-153		I	Inactivated by FDA		2026-10-12
excluded package	package	53634-153	53634-153-01	I	Inactivated by FDA		2026-10-12

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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`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	53634-153-01	`1332a3947898…`	`d4bfe170f9cd…`

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53634-153-01	2024-01-30	C162847	48780-1	1030e365-6797-111a-e063-dadaa90a10e2	salicylic gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53634-153-01	salicylic gel	15 mL in 1 TUBE	GEL	15		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53634-153	SALICYLIC GEL (SALICYLIC ACID) GEL [MALIN AND GOETZ INC]	1	Legacy NDC, 1 package rows	20221202_ee2acdf0-e5dc-9691-e053-2995a90ab49e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acne Free Free 24 HR Acne Clearing System	BENZOYL PEROXIDE	AcneFree, LLC	c939847a-72eb-96fa-e053-2a95a90a4f9c	2026-07-31	Warnings	Exact identifier application number: M006
Terminator 10	BENZOYL PEROXIDE	AcneFree, LLC	c06778b6-0ed6-7d82-e053-2a95a90a2ef8	2026-07-31	Warnings	Exact identifier application number: M006
Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide	BENZOYL PEROXIDE	AcneFree LLC	c939847a-72cc-96fa-e053-2a95a90a4f9c	2026-07-31	Warnings	Exact identifier application number: M006
Benzoyl Peroxide Deep Cleansing Foaming Wash	BENZOYL PEROXIDE	AcneFree, LLC	fe2d0e24-8c68-b2ea-e053-6294a90ad72c	2026-07-31	Warnings	Exact identifier application number: M006
Salicylic Acid	SALICYLIC ACID	Acne Free, LLC	1097fc73-fa47-0f14-e063-6294a90aa499	2026-07-31	Warnings	Exact identifier application number: M006
Even and Clear Cleanser	SALICYLIC ACID	Ambi Enterprises LLC	bff537cf-aa79-5250-e053-2995a90a388a	2026-07-31	Warnings	Exact identifier application number: M006
Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne Cleanser	BENZOYL PEROXIDE	AcneFree, LLC	c7a675fa-b6c0-6237-e053-2a95a90a0406	2026-07-31	Warnings	Exact identifier application number: M006
Acne Free SEVERE ACNE 24 HR Acne Clearing System	BENZOYL PEROXIDE	AcneFree, LLC	c939681e-ea93-31ce-e053-2a95a90a8c70	2026-07-31	Warnings	Exact identifier application number: M006
Acne Free SENSITIVE SKIN 24 HR Acne Clearing System	SALICYLIC ACID, BENZOYL PEROXIDE	AcneFree LLC	c9397a25-8fed-48d0-e053-2a95a90ab495	2026-07-31	Warnings	Exact identifier application number: M006
sulfur acne treatment	SULFUR	Acne Free	105545d8-974c-5a9a-e063-6294a90aecc4	2026-07-31	Warnings	Exact identifier application number: M006
24 Hour Sensitive Skin Acne Clearing System	SALICYLIC ACID	Acne Free LLC	39ea674d-ff6e-a8c6-e063-6394a90a0656	2026-07-31	Warnings	Exact identifier application number: M006
cardae FOLLICULITIS Cream	MICONAZOLE NITRATE 2% FOLLICULITIS CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57e0be6a-3141-f3b6-e063-6394a90a1520	2026-07-30	Warnings	Exact identifier application number: M006
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENT	SALICYLIC ACID	Gold Inti Trade Corporation	57a7c929-31f5-ef82-e063-6394a90ab9af	2026-07-28	Warnings	Exact identifier application number: M006
Acne Treatment with Sulfur	SULFUR	DLC Laboratories, Inc.	4a1591e8-6135-4b22-b54c-5553c2dc0540	2026-07-28	Warnings	Exact identifier application number: M006
amberglow BLEMISH PATCHES	SALICYLIC ACID	Pearl World Inc.	12054430-25ff-4b72-8f64-822b27abb443	2026-07-27	Warnings	Exact identifier application number: M006
RFA BPO Acne Treatment 2.5%	BENZOYL PEROXIDE	Topiderm, Inc.	c5053e9e-7608-45d9-9b9b-9b93210eb917	2026-07-27	Warnings	Exact identifier application number: M006
ACNO Solution ACNE TREATMENT	SALICYLIC ACID	Noon Aesthetics M.R. Ltd	4a267e44-03d9-471f-9708-a5c60ff69097	2026-07-24	Warnings	Exact identifier application number: M006
DERMFREE MILIA REMOVER	SALICYLIC ACID 1% MILIA REMOVER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5c8a6e-b02d-3a87-e063-6294a90a14ff	2026-07-23	Warnings	Exact identifier application number: M006
salicylic acid	SALICYLIC ACID	Chain Drug Marketing Association	4dc96074-50a1-baa8-e063-6294a90a5aab	2026-07-22	Warnings, Adverse reactions	Exact identifier application number: M006
SYLVIRENE MILIA REMOVER	SALICYLIC ACID 1% MILIA REMOVER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a3751f8-2365-1b34-e063-6394a90acf74	2026-07-21	Warnings	Exact identifier application number: M006

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
346298	salicylic acid 2 % Topical Gel	PSN	ee2acdf0-e5dc-9691-e053-2995a90ab49e	1
346298	salicylic acid 0.02 MG/MG Topical Gel	SCD	ee2acdf0-e5dc-9691-e053-2995a90ab49e	1
346298	salicylic acid 2 % Topical Gel	SY	ee2acdf0-e5dc-9691-e053-2995a90ab49e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53634-153-01	53634015301	15 mL in 1 TUBE (53634-153-01)	15 ml	2022-11-23	0000-00-00	No	No	Current