salicylic gel

Product NDC: 53634-153
Requested package NDC: 53634-153-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53634-153	53634-153-01	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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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 43 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens 3 Step Acne System	BENZOYL PEROXIDE	WALGREEN COMPANY	f7933ecd-4fc7-8526-e053-6394a90a15c5	2024-10-11	Warnings	Exact identifier application number: M006
ClearSynergy	SALICYLIC ACID	SRL Enterprises, LLC	b0ad3d4c-7afa-4503-b5d6-c88bf898155e	2024-10-08	Warnings	Exact identifier application number: M006
Asepxia Acne Treatment	SALICYLIC ACID	Genomma Lab USA	910d4320-bf89-436a-a8d4-54d001281dee	2024-10-08	Warnings	Exact identifier application number: M006
Asepxia Acne	SALICYLIC ACID	Genomma Lab USA	9e8de726-480c-44c7-82c8-ce66412d881e	2024-10-07	Warnings	Exact identifier application number: M006
benzoyl peroxide	BENZOYL PEROXIDE	Bryant Ranch Prepack	d3f16759-1ddf-4cfc-8b93-f60e680ba2f8	2024-10-03	Warnings	Exact identifier application number: M006
Atrix Clarifying Toner	SALICYLIC ACID	PureTek Corporation	191a2f96-eb97-4b45-b6a8-0d5835e7e757	2024-10-02	Warnings	Exact identifier application number: M006
ZO Skin Health Retinol Plus Acne Complex	SALICYLIC ACID	ZO Skin Health, Inc.	1d65e4d2-0856-9135-e063-6294a90a5c66	2024-10-01	Warnings	Exact identifier application number: M006
Atrix Acne Treatment	SALICYLIC ACID	PureTek Corporation	ba106b20-32aa-df90-e053-2995a90adaef	2024-10-01	Warnings	Exact identifier application number: M006
Atrix Antibacterial Wash	SALICYLIC ACID	PURETEK CORPORATION	bd5b6f29-5b97-0853-e053-2a95a90aed59	2024-10-01	Warnings	Exact identifier application number: M006
Target Up and Up Salicylic Acid Acne Wash	SALICYLIC ACID	TARGET CORPORATION	235aa04e-746f-d66a-e063-6394a90a1144	2024-09-30	Warnings	Exact identifier application number: M006
Target Up and Up Benzoyl Peroxide Acne Wash	BENZOYL PEROXIDE	TARGET CORPORATION	235b9df0-41dd-5476-e063-6394a90ae668	2024-09-30	Warnings	Exact identifier application number: M006
Target Up and Up Moisturizer with Salicylic Acid Acne Treatment	SALICYLIC ACID	TARGET CORPORATION	235ca067-e2d4-ca01-e063-6394a90a1050	2024-09-30	Warnings	Exact identifier application number: M006
Acne Phage Serum	ENCAPSULATED SALICYLIC ACID	Allure Labs	230d173f-92c1-2e98-e063-6394a90acb21	2024-09-26	Warnings	Exact identifier application number: M006
MDacne Customized Acne Treatment Sulfur	SULFUR	MDAlgorithms Inc	236e7d89-006f-07ac-e063-6394a90ab82b	2024-09-26	Warnings	Exact identifier application number: M006
MDacne Customized Acne Treatment Benzoyl Peroxide	BENZOYL PEROXIDE	MDAlgorithms Inc	236e8d2e-ccd4-0a15-e063-6394a90a73e9	2024-09-26	Warnings	Exact identifier application number: M006
Topicals Clearly Mist	SALICYLIC ACID	Topiderm, Inc.	1f1d6751-9566-4738-a28b-f501425b6b21	2024-09-24	Warnings	Exact identifier application number: M006
Aveeno Positively Radiant Clear Complexion Daily Moisturizer	SALICYLIC ACID	Kenvue Brands LLC	e426681d-9738-c7ab-e053-2a95a90a9ab3	2024-09-23	Warnings	Exact identifier application number: M006
Oxy Maximum Strength Acne Cream Cleanser	OXY MAXIMUM STRENGTH ACNE CREAM CLEANSER	The Mentholatum Company	22ccdcc2-4ee5-2363-e063-6394a90a9594	2024-09-23	Warnings	Exact identifier application number: M006
MDacne Customized Acne Treatment Salicylic Acid	SALICYLIC ACID	MDAlgorithms Inc	3eae8b39-d2c2-4cf7-8c56-7fbaec481fc7	2024-09-19	Warnings	Exact identifier application number: M006
MDacne Customized Acne Treatment Benzoyl Peroxide	BENZOYL PEROXIDE	MDAlgorithms Inc	a1f38604-9a42-400d-851e-148d0dc9c86b	2024-09-19	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