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		2026-10-15
excluded package	package	53634-153	53634-153-01	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	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 24 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
YOUR ANTI-ACNE SERUM	SALICYLID ACID	Skin Ai, LLC	410d1968-6931-7a48-e063-6294a90abb62	2025-10-13	Warnings	Exact identifier application number: M006
GENTLE ACNE SERUM	SALICYLIC ACID	Drmtlgy, LLC	a8e41339-3f3b-44ad-9b2f-1962d5f66f3d	2025-10-10	Warnings	Exact identifier application number: M006
30 day Acne Treatment Kit	SALICYLIC ACID, BENZOYL PEROXIDE	Cosmetic Enterprises Ltd	039ac054-3eb2-5beb-e063-6394a90a561a	2025-10-10	Warnings	Exact identifier application number: M006
Breakout Control Bioelements	BENZOYL PEROXIDE	Cosmetic Enterprises Ltd	94462332-2169-4ea1-86b3-25ab9646c6e5	2025-10-10	Warnings	Exact identifier application number: M006
Anti Bac Acne Clearing	BENZOYL PEROXIDE	Cosmetic Enterprise Ltd	7f6ee76b-c664-2ec4-e053-2991aa0a9488	2025-10-10	Warnings	Exact identifier application number: M006
Clear Acne Body Paulas Choice	SALICYLIC ACID	Cosmetic Enterprises Ltd	46cb9ff7-0f8f-457f-b4bb-6f3350224375	2025-10-10	Warnings	Exact identifier application number: M006
Clear Exfoliating Solution Paulas Choice	SALICYLIC ACID	Cosmetic Enterprises Ltd	f84a2b7e-1e02-450f-b290-b4f6f87cdb7a	2025-10-10	Warnings	Exact identifier application number: M006
Starface Acne Spot Treatment	SALICYLIC ACID	Starface World, Inc.	f8cfd5b0-317e-4646-9885-71ecad29ba1c	2025-10-07	Warnings	Exact identifier application number: M006
Skin Bliss Mist	SALICYLIC ACID	Matrix Beauty LLC	de280fa0-f993-4ccc-bc92-4a8311b5e7ee	2025-10-07	Warnings	Exact identifier application number: M006
skinlycious Clear skin complete starter kit	SALICYLIC ACID	Skinlycious Pte Ltd	ab1609b7-a10b-44f3-ab86-a615967b2a57	2025-10-03	Warnings	Exact identifier application number: M006
Skinlycious Clear Skin Essentials Starter kit	SALICYLIC ACID	Skinlycious Pte Ltd	af2d8318-cbff-4317-adb7-828a92af7868	2025-10-03	Warnings	Exact identifier application number: M006
Skinlycious Glow Exfoliant	SALICYLIC ACID	Skinlycious Pte Ltd	4baa8342-e983-43bb-9864-caf14bff21e3	2025-10-03	Warnings	Exact identifier application number: M006
Viaderma Clear Acne Treatment	SALICYLIC ACID	ViaDerma Distribution, Inc.	aa62d4b5-1e46-41bf-a9b6-69ae005fd79a	2025-10-02	Warnings	Exact identifier application number: M006
Caring Mill Acne Clearing Cleanser	SALICYLIC ACID	FSA Store Inc. (Caring Mills)	4038bf3f-d6b9-48a2-e063-6394a90aea6b	2025-10-02	Warnings	Exact identifier application number: M006
Killa Extra Strength 2 pack	SALICYLIC ACID	ZitSticka, Inc.	fc9922ba-5164-5837-e053-6294a90a3de5	2025-10-01	Warnings	Exact identifier application number: M006
Acne Toner Serum	SALICYLIC ACID	Dime Beauty Co, LLC	e5c35684-e8b5-70fd-e053-2a95a90aedae	2025-10-01	Warnings	Exact identifier application number: M006
Acne Spot Treatment	SALICYLIC ACID	Dime Beauty Co, LLC	f7fd3f24-7c27-b45b-e053-6394a90a50ae	2025-10-01	Warnings	Exact identifier application number: M006
Creamy Foam Cleanser	SALICYLIC ACID	Dime Beauty Co, LLC	e39f41ed-0909-9f0e-e053-2995a90ab36a	2025-10-01	Warnings	Exact identifier application number: M006
DETOX DROPS ACNE TONER	ACNE TONER	KENDO HOLDINGS INC.	35bcdb22-550e-b27c-e063-6294a90a2e5b	2025-09-30	Warnings	Exact identifier application number: M006
Neutrogena Evenly Clear Acne Exfoliant	SALICYLIC ACID	Kenvue Brands LLC	3f90696e-1ece-78be-e063-6294a90a5c6a	2025-09-26	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