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.
| 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.
| 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 | 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 |
|---|---|---|---|---|---|---|
| Acne Control | CREAM | Walgreen | fc60cccb-405b-e49e-e053-6394a90a5a12 | 2023-09-11 | Warnings | M006 |
| AnubisMed | AZELAIC ACID, SALICYLIC ACID | ANUBIS COSMETICS SL | ebf3153d-30f5-54e4-e053-2995a90a74b1 | 2023-09-05 | Warnings | M006 |
| AnubisMed | GLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACID | ANUBIS COSMETICS SL | eca95dde-cb57-2ab6-e053-2995a90af84f | 2023-09-05 | Warnings | M006 |
| Anubis Barcelona | PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOIN | ANUBIS COSMETICS SL | eb9244ea-6102-3cbe-e053-2a95a90ab8f6 | 2023-09-01 | Warnings | M006 |
| Anubis Barcelona Regul Oil | PROPYLENE GLYCOL, PANTHENOL, THIAMINE HCL | ANUBIS COSMETICS SL | eb8e5beb-4452-58c2-e053-2a95a90a66e0 | 2023-09-01 | Warnings | M006 |
| Anubis Barcelona Regul Oil | CETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE | ANUBIS COSMETICS SL | eb68c3ab-7835-1a1c-e053-2995a90a0d66 | 2023-09-01 | Warnings | M006 |
| Anubis Barcelona Regul OIl | PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT | ANUBIS COSMETICS SL | eb905bd0-c600-b8b2-e053-2995a90ad259 | 2023-09-01 | Warnings | M006 |
| Anubis Barcelona Regul Oil | PROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACT | ANUBIS COSMETICS SL | eb7c418b-8bee-26a3-e053-2a95a90a4e96 | 2023-09-01 | Warnings | M006 |
| ACNE CLEANSING | SALICYLIC ACID | CLINIQUE LABORATORIES LLC | 7bae5802-cf51-4b41-9d7c-d72f1eb4c4af | 2023-08-30 | Warnings | M006 |
| Gly-Sal 2-2 Pads | SALICYLIC ACID | Topiderm, Inc. | a92a9ffb-5c5b-43a4-b669-04667324920b | 2023-02-16 | Warnings | M006 |
| Derma E Acne Clarifying Mask | SULFUR | derma e | 55df8fb4-abc3-43fe-b89b-6e7d638b27a6 | 2023-02-14 | Warnings | M006 |
| Replenix Acne Gly-Sal 2-2 Foaming Cleanser | SALICYLIC ACID | Topiderm, Inc. | 811dbf95-2b39-45c5-99a2-33c3c9d19570 | 2019-12-19 | Warnings | M006 |
| REPLENIX ACNE SOLUTIONS WASH | BENZOYL PEROXIDE | Topiderm, Inc. | 8dc2d27d-3cc4-4874-b4c2-32607849b205 | 2019-12-17 | Warnings | M006 |
| REPLENIX ACNE Solution BENZOYL PEROXIDE WASH | BENZOYL PEROXIDE | Topiderm, Inc. | 235e9dd5-13f2-4078-9807-1d87fd9e6cba | 2019-12-17 | Warnings | M006 |
| Replenix Acne | BENZOYL PEROXIDE | Topiderm, Inc | 03d4c298-8f44-41f7-b086-96ae836152bb | 2019-10-31 | Warnings | M006 |
| Replenix Acne | BENZOYL PEROXIDE | Topiderm, Inc. | c12f9005-a549-4447-9beb-df7126f77df1 | 2019-10-31 | Warnings | M006 |
| Gly-Sal 10-2 Pads | SALICYLIC ACID | Topiderm, Inc. | b39e845d-4c40-4f9e-9cb5-a8386f326652 | 2019-10-23 | Warnings | M006 |
| Gly-Sal 5-2 Pads | SALICYLIC ACID | Topiderm, Inc. | e73bd26c-cdc2-47ab-94e8-3bc49a9b19e8 | 2019-10-22 | Warnings | M006 |
| SKIN MEDICA Purifying Foaming Wash | SALICYLIC ACID | Allergan, Inc. | 064d9e2b-077f-4229-b653-666fc5479ae2 | 2013-03-01 | 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 |