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 42 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meijer Oil Free Acne Wash Pink Grapefruit Foaming Scrub	SALICYLIC ACID	MEIJER DISTRIBUTION, INC	8f8754d8-85ff-0e64-e053-2995a90a7c21	2024-10-16	Warnings	Exact identifier application number: M006
KROGER CLARIFY CARE ACNE WASH	SALICYLIC ACID	THE KROGER COMPANY	c8eaada4-142f-4e64-e053-2995a90a9844	2024-10-15	Warnings	Exact identifier application number: M006
H.E.B. Oil Free Daily Acne Scrub	SALICYLIC ACID	H.E.B	df2b8b89-e4d1-4745-e053-2995a90aed01	2024-10-15	Warnings	Exact identifier application number: M006
Walgreens Acne Control Gel	SALICYLIC ACID	WALGREEN COMPANY	ffc4c35b-1390-951b-e053-6294a90a1b11	2024-10-14	Warnings	Exact identifier application number: M006
Walgreens Maximum Strength Tinted Acne Spot Treatment Cream	BENZOYL PEROXIDE	WALGREEN COMPANY	fa3f4356-ff1c-5ff1-e053-6394a90a7279	2024-10-14	Warnings	Exact identifier application number: M006
Walgreens Maximum Strength Acne Gel	BENZOYL PEROXIDE	WALGREEN COMPANY	fd7dd2eb-03a6-ef1f-e053-6294a90a8557	2024-10-14	Warnings	Exact identifier application number: M006
WALGREENS ALL PURPOSE PSORIASIS WASH	SALICYLIC ACID	WALGREEN COMPANY	a9e00927-5bc2-c6da-e053-2a95a90afa5a	2024-10-14	Warnings	Exact identifier application number: M006
WALGREENS DAILY REPAIR PSORIASIS MOISTURIZER	SALICYLIC ACID	WALGREEN COMPANY	a9e07cd1-b788-b9bc-e053-2995a90a897d	2024-10-14	Warnings	Exact identifier application number: M006
WALGREENS APRICOT SCRUB ACNE TREATMENT	SALICYLIC ACID	WALGREEN COMPANY	c0081097-424c-4ebf-ae9e-750650e67e69	2024-10-14	Warnings	Exact identifier application number: M006
Up and Up Acne Wash	SALICYLIC ACID	TARGET CORPORATION	93410bbe-4dd7-12db-e053-2995a90a2c96	2024-10-14	Warnings	Exact identifier application number: M006
Target Up and Up Oil Free Acne Wash Pink Grapefruit Foaming Scrub	SALICYLIC ACID	TARGET CORPORATION	baec4311-d07e-bd70-e053-2a95a90ad404	2024-10-14	Warnings	Exact identifier application number: M006
TARGET UP AND UP ACNE MEDICATION	BENZOYL PEROXIDE	TARGET CORPORATION	badbe092-eaff-1163-e053-2a95a90abb6e	2024-10-14	Warnings	Exact identifier application number: M006
Target Up and Up Acne Spot Treatment	BENZOYL PEROXIDE	TARGET CORPORATION	f12eface-bf9c-33fd-e053-2a95a90a7b35	2024-10-14	Warnings	Exact identifier application number: M006
Target Up and Up 3 Step Acne System	BENZOYL PEROXIDE	TARGET CORPORATION	f784bd99-0b8a-2521-e053-6294a90a2519	2024-10-14	Warnings	Exact identifier application number: M006
Up and Up Blemish Controlling Apricot Scrub	SALICYLIC ACID	TARGET CORPORATION	92d44bd6-bea8-6134-e053-2995a90ad120	2024-10-14	Warnings	Exact identifier application number: M006
Up and Up Deep Clean Toner	SALICYLIC ACID	TARGET CORPORATION	945b0588-6864-27bc-e053-2995a90a73e3	2024-10-14	Warnings	Exact identifier application number: M006
SIGNATURE CARE BLEMISH AND BLACKHEAD CONTROL	SALICYLIC ACID	SAFEWAY, INC.	a573c428-870d-0bf7-e053-2995a90a595a	2024-10-14	Warnings	Exact identifier application number: M006
SIGNATURE CARE ACNE MEDICATION	BENZOYL PEROXIDE	SAFEWAY, INC.	a62af431-b033-3603-e053-2995a90a961e	2024-10-14	Warnings	Exact identifier application number: M006
Signature Care Oil Free Acne Wash Pink Grapefruit Foaming Scrub	SALICYLIC ACID	Safeway, Inc.	baee746b-cb5d-3621-e053-2a95a90a302f	2024-10-14	Warnings	Exact identifier application number: M006
Walgreens Acne Spot Treatment	BENZOYL PEROXIDE	WALGREEN COMPANY	f12d432e-3115-47ec-e053-2a95a90a69d3	2024-10-11	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