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 4 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SERYNTH MILIA REMOVER	SALICYLIC ACID 1% MILIA REMOVER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c3bfa-32ec-c0dd-e063-6394a90ab15c	2026-07-21	Warnings	Exact identifier application number: M006
OURUI ONE FACIAL BUMP REFINING ESSENCE	SALICYLIC ACID 0.25% FACIAL BUMP REFINING ESSENCE	Jiangxi Yudexi Pharmaceutical Co., LTD	4959bb67-063f-ffa4-e063-6394a90aa01f	2026-07-20	Warnings	Exact identifier application number: M006
Beilloso FACIAL BUMP REFINING ESSENCE	SALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a461a7a-f5cf-6544-e063-6294a90a00f2	2026-07-20	Warnings	Exact identifier application number: M006
Lepnuns MILIA REMOVER	DIDECYL DIMETHYL AMMONIUM CHLORIDE 0.025% MILIA REMOVER	Jiangxi Yudexi Pharmaceutical Co., LTD	497ed53c-2562-b370-e063-6294a90a5ba1	2026-07-20	Warnings	Exact identifier application number: M006
Good Molecules Acne Foaming Cleanser	SALICYLIC ACID	Good Molecules, LLC	44fa9eda-0910-7d70-e063-6394a90af3a7	2026-07-20	Warnings	Exact identifier application number: M006
Good Molecules Acne Foaming Cleanser	SALICYLIC ACID	Good Molecules	dec189a2-5f93-7c3e-e053-2a95a90af988	2026-07-20	Warnings	Exact identifier application number: M006
Clean and Clear Essentials Acne Toner	SALICYLIC ACID	Kenvue Brands LLC	06cd03e3-6146-65d8-e063-6294a90a1701	2026-07-17	Warnings	Exact identifier application number: M006
24 Hour Acne Serum	BENZOYL PEROXIDE	Drmtlgy, LLC	55507941-dbdf-4e5f-a74d-4da6f67b6a1f	2026-07-17	Warnings	Exact identifier application number: M006
PCA Skin Acne Control Prebiotic Cleanser	SALICYLIC ACID	CP Skin Health Group, Inc.	56bca675-3e59-815a-e063-6294a90a1d87	2026-07-16	Warnings	Exact identifier application number: M006
Acne patches	ACNE PATCHES	Shenzhen Hengdasheng Technology Co., Ltd	5664b9c4-6ae3-4f64-e063-6294a90a825a	2026-07-14	Warnings	Exact identifier application number: M006
Zmztuhua Folliculitis Treatment Cream	BENZOYL PEROXIDE	Guangzhou Hechuang Commercial Service Co.,Ltd.	567ceafc-b75a-9777-e063-6394a90ae160	2026-07-13	Warnings	Exact identifier application number: M006
Magnilife Eczema Care	SULFUR, GRAPHITE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS WHOLE	The Magni Group, Inc.	8e3fc743-4c82-4a03-a963-2d5f93a1bc26	2026-07-13	Warnings	Exact identifier application number: M006
PHYLA ACNE PHAGE SERUM	SALICYLIC ACID	COSMAX USA, CORP	564abe82-c983-6a98-e063-6394a90a14a0	2026-07-10	Warnings	Exact identifier application number: M006
GOOD MOLECULE MAXIMUM STRENGHT ACNE	SALICYLIC ACID	COSMAX USA, CORP	564aafc0-1a06-1cba-e063-6294a90ae738	2026-07-10	Warnings	Exact identifier application number: M006
Touch Acne Treatment Benzoyl Peroxide	BENZOYL PEROXIDE	Diractions Capital LLC	1ae4e081-b04a-407d-992d-cd398f3afc54	2026-07-10	Warnings	Exact identifier application number: M006
Drs. ACNE SPOT TREATMENT	SALICYLIC ACID	OL PHARMA TECH, LLC Drs. PHARMACY	161b2306-364a-e1b8-e063-6394a90a6c88	2026-07-09	Warnings	Exact identifier application number: M006
Proactiv Acne Body Wash	SALICYLIC ACID	Alchemee, LLC	36aef223-6a4a-433f-b292-631e6068b17f	2026-07-08	Warnings	Exact identifier application number: M006
Ladoverna	BENZOYL PEROXIDE CREAM	Guangzhou Oupeng Cosmetics Co., Ltd.	55b0f9fd-9055-6969-e063-6294a90a1a7d	2026-07-07	Warnings	Exact identifier application number: M006
L BRI Klearaway	SALICYLIC ACID	L'BRI Health & Beauty	b9aa1c48-b767-47b0-bb98-efb7e860ab36	2026-07-06	Warnings	Exact identifier application number: M006
L BRI Deep Clean Toner	SALICYLIC ACID	L'BRI Health & Beauty	607fb6d0-ae49-472c-9224-0673af934bd2	2026-07-06	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