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.
| 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.
| 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 | 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 | 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53634-153-01 | salicylic gel | 15 mL in 1 TUBE | GEL | 15 | 1 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 10% Azelaic Acid | AZELAIC ACID CREAM | Guangzhou Ariel Medical Technology Co., Ltd. | 55b03daa-b6d4-9edf-e063-6394a90ac4d1 | 2026-07-03 | Warnings | M006 |
| Hero Mighty Cleanser | SALICYLIC ACID | Church & Dwight Co., Inc. | 5597df54-2e58-0d6a-e063-6394a90a1697 | 2026-07-01 | Warnings | M006 |
| Hero Pore Cleanser | SALICYLIC ACID | Church & Dwight Co., Inc. | 559987c0-7abe-13fc-e063-6294a90a9f27 | 2026-07-01 | Warnings | M006 |
| Acne Treatment Cream | 2% SALICYLIC ACID | Zytrell Skin Solutions Inc. | 555be487-92d8-6220-e063-6394a90a0c0a | 2026-06-28 | Warnings | M006 |
| SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENT | SALICYLIC ACID | Longway Technology(Guangzhou)Co., Ltd. | 553957ef-cb8a-e75d-e063-6394a90a261b | 2026-06-27 | Warnings | M006 |
| ORLASKIN ACNE Treatment | SALICYLIC ACID | Guangzhou Yapheon Health Industry Co., Ltd. | 552bf5df-0a3c-7c10-e063-6394a90a311f | 2026-06-26 | Warnings | M006 |
| ORLASKIN SALICYLIC ACID ACNE TREATMENT PADS | SALICYLIC ACID | Guangzhou Yapheon Health Industry Co., Ltd. | 552c9e72-db4b-641a-e063-6294a90a2901 | 2026-06-26 | Warnings | M006 |
| CosmoClear Cleanser | SALICYLIC ACID | Noon Aesthetics M.R. Ltd | dd738dfd-676b-40fe-8b0e-3d8305e0fdcb | 2026-06-25 | Warnings | M006 |
| Walgreens Acne Foaming Cleanser | BENZOYL PEROXIDE | WALGREEN COMPANY | 549fddb8-9d42-16cb-e063-6294a90aa2a9 | 2026-06-19 | Warnings | M006 |
| Walgreens Maximum Strength Acne Treatment | BENZOYL PEROXIDE | WALGREEN COMPANY | 548e327b-1a4f-03df-e063-6294a90a3932 | 2026-06-18 | Warnings | M006 |
| Epoch | SALICYLIC ACID | NSE Products, Inc. | 3084ac37-de1f-4218-9471-6a5ebf720eb9 | 2026-06-17 | Warnings | M006 |
| VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZER | SALICYLIC ACID | LOreal USA Products Inc | 17b7a58b-97f2-429f-83cb-db04631d307d | 2026-06-16 | Warnings | M006 |
| VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZER | SALICYLIC ACID | Cosmetique Active Production | 17b8a58b-97f2-429f-83cb-db04631d307d | 2026-06-16 | Warnings | M006 |
| Societe Clarity Bac | SALICYLIC ACID | Societe Clinical Skincare | 545130ce-46f9-c231-e063-6394a90a1ea8 | 2026-06-16 | Warnings | M006 |
| ES Salicylic Wash | SALICYLIC ACID | Elaine Sterling Enterprises | 543ab052-5aa9-6585-e063-6394a90af88f | 2026-06-16 | Warnings | M006 |
| Societe Clear Skin Pads | SALICYLIC ACID | Societe Clinical Skincare | 543a4347-d7d8-3050-e063-6294a90ab3a2 | 2026-06-16 | Warnings | M006 |
| FHF Crisp Start | ACNE CLEANSER | Summer Soles LLC dba Farmhouse Fresh Goods | 54391292-263d-253e-e063-6394a90a742f | 2026-06-16 | Warnings | M006 |
| FHF Change Peel Pads | SALICYLIC PADS | Summer Soles, LLC dba Farmhouse Fresh Goods | 5439a9dd-786c-9140-e063-6394a90a8fa9 | 2026-06-16 | Warnings | M006 |
| FHF Day Breakthru | SALICYLIC SERUM | Summer Doles dba Farmhouse Fresh Fresh Goods | 54397bb7-1845-72a7-e063-6394a90abbd1 | 2026-06-16 | Warnings | M006 |
| Societe Daily Exfoliation | SALICYLIC ACID | Societe Clinical Skincare | 54633a24-3761-14d7-e063-6294a90a89f9 | 2026-06-16 | Warnings | M006 |
DailyMed RxNorm Mappings#
| 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 | 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 |