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 46 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment	SALICYLIC ACID	L'Oreal USA Products Inc	74c49388-3314-47e8-80b1-19c09e6ea1f9	2024-07-14	Warnings	Exact identifier application number: M006
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment	SALICYLIC ACID	COSMETIQUE ACTIVE PRODUCTION	873de079-8b8d-45cd-8c7c-4645818f5aaa	2024-07-14	Warnings	Exact identifier application number: M006
Dr. Zenovia Clear Complexion	SALICYLIC ACID	Topiderm, Inc.	4ff9b26d-3cd9-4539-b389-edd2df24a466	2024-06-28	Warnings	Exact identifier application number: M006
LEROSETT Botanical Acne Cleanser	SALICYLIC ACID	GUNILLA OF SWEDEN, INC.	8b31d155-c257-4452-9e22-0c69fa36173e	2024-06-27	Warnings	Exact identifier application number: M006
SkinCeuticals Silymarin CF Acne Treatment Antioxidant	SALICYLIC ACID	Cosmetique Active Production	fcc3c44b-3090-45b5-91e4-e591c92a08c8	2024-06-24	Warnings	Exact identifier application number: M006
Peace Out Early Stage Acne Dot	SALICYLIC ACID	Peace Out LLC.	0632d458-d326-ade4-e063-6294a90af3ba	2024-06-20	Warnings	Exact identifier application number: M006
Replenix BP Acne	BENZOYL PEROXIDE	Topiderm, Inc.	f449e020-a4d8-4a1b-82eb-4dc59e99b8d4	2024-06-18	Warnings	Exact identifier application number: M006
b pure Pressed Powder for Acne Prone Skin Fair	SALICYLIC ACID	Fourstar Group USA, Inc.	ecf22bd1-4fc3-4455-ae01-13f97f53dc34	2024-06-17	Warnings	Exact identifier application number: M006
b pure Pressed Powder for Acne Prone Skin Tan	SALICYLIC ACID	Fourstar Group USA, Inc.	1158f6c2-2b59-4ed3-8d28-73b6da885a5d	2024-06-17	Warnings	Exact identifier application number: M006
Gly-Sal 10-2	SALICYLIC ACID	Topiderm, Inc.	661cc58b-9360-4b96-b405-afdc2e378397	2024-06-13	Warnings	Exact identifier application number: M006
BLAIR and JACK Anti-Bump Acne Treatment	BENZOYL PEROXIDE	Blair + Jack	aa8df86a-639c-4416-aadf-4b58566ed9f1	2024-06-11	Warnings	Exact identifier application number: M006
b pure Blemish Concealer for Acne Prone Skin Nude	SALICYLIC ACID	Fourstar Group USA, Inc.	76e91277-1fb4-490b-b351-39d626bc1fc2	2024-06-11	Warnings	Exact identifier application number: M006
b pure Blemish Concealer for Acne Prone Skin Fair	SALICYLIC ACID	Fourstar Group USA, Inc.	764599e5-2ec3-4223-819e-36415fd915f7	2024-06-11	Warnings	Exact identifier application number: M006
Dr. Zenovia Acne Cleanser	BENZOYL PEROXIDE	Topiderm, Inc.	00fb1ee5-6076-4980-8507-9e58a96e6a6b	2024-06-11	Warnings	Exact identifier application number: M006
Dr. Zenovia Spot Treatment	BENZOYL PEROXIDE	Topiderm, Inc.	dfdb3d8e-4d39-4ce4-851f-80b11972ca9e	2024-06-11	Warnings	Exact identifier application number: M006
Rugby Benzoyl Peroxide Acne Medication	BENZOYL PEROXIDE	NuCare Pharmaceuticals,Inc.	69bd4f4c-017a-7422-e053-2991aa0aa655	2024-06-10	Warnings	Exact identifier application number: M006
Thayers Natural Remedies Since 1847 Rapid Acne Treatment	SULFUR	L'Oreal USA Products Inc	d7cc3c06-2f89-4c0b-b121-fdd53638b625	2024-06-07	Warnings	Exact identifier application number: M006
Differin 10% BPO Acne Treatment	BENZOYL PEROXIDE	Galderma Laboratories, L.P.	05468eab-f239-42cb-9106-055a105f0fa5	2024-06-06	Warnings	Exact identifier application number: M006
2.5 Acne Med	BENZOYL PEROXIDE	Face Reality, Inc.	58a7f677-996c-4951-8e5d-b5556244f800	2024-06-05	Warnings	Exact identifier application number: M006
10 Acne Med	BENZOYL PEROXIDE	Face Reality, Inc.	91791905-086f-44cf-9c1a-e9f132c6c11b	2024-06-05	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