Overview
A compound obtained from the bark of the white willow and wintergreen leaves, and also prepared synthetically. It has bacteriostatic, fungicidal, and keratolytic actions. Its salts, the salicylates, are used as analgesics.
Indication
Key additive in many skin-care products for the treatment of acne, psoriasis, callouses, corns, keratosis pilaris and warts.
Associated Conditions
- Acne
- Actinic Keratosis (AK)
- Alopecia Areata (AA)
- Atopic Dermatitis
- Blackheads
- Chronic Eczema
- Contact Dermatitis
- Corns
- Dandruff
- Dermatitis, Eczematous of the scalp
- Discoid Lupus Erythematosus (DLE)
- Foot Callus
- Fungal Infections
- Fungal skin infection
- Furuncle
- Hand Eczema
- Hyperkeratosis
- Hyperkeratosis follicularis et parafollicularis
- Infections, Fungal of the Skin Folds
- Infections, Fungal of the face
- Infections, Fungal of the feet
- Infections, Fungal of the hand
- Lichen
- Lichen Planopilaris
- Lichen Planus (LP)
- Lichen simplex chronicus
- Lupus Erythematosus, Chronic Cutaneous
- Molluscum Contagiosum
- Musculoskeletal Pain
- Neurodermatitis
- Palmoplantar Pustulosis (PPP)
- Palmoplantar keratoderma
- Plantar Warts
- Pruritus
- Psoriasis
- Psoriasis Vulgaris (Plaque Psoriasis)
- Psoriasis of the scalp
- Rash
- Ringworm of the Skin
- Ringworm of the scalp
- Seborrheic Dermatitis
- Seborrhoea of the scalp
- Seborrhoeic Dermatitis of the Scalp
- Verruca (Warts)
- Verrucous Psoriasis
- Bacterial skin infections
- Calluses
- Corticosteroid-responsive dermatoses
- Keratinization disorders
- Scaling
- Scaling of skin
- Superficial Fungal skin infection
Research Report
Salicylic Acid (DB00936): A Comprehensive Monograph on its Chemistry, Pharmacology, and Clinical Utility
Executive Summary
Salicylic acid (DrugBank ID: DB00936) is a beta-hydroxy acid that occupies a unique and enduring position in the therapeutic landscape, functioning as both a widely accessible over-the-counter (OTC) agent and a potent prescription medication. Its primary mechanism of action in dermatology is as a desmolytic and keratolytic agent, enabling it to effectively remove the outer layer of the stratum corneum.[1] This core function underpins its broad spectrum of clinical applications, which range from the management of acne vulgaris and dandruff to the treatment of more severe hyperkeratotic disorders such as psoriasis, ichthyosis, and warts.[1] The therapeutic and toxicological profile of salicylic acid is critically dependent on its concentration, which dictates its function from a gentle exfoliant to a potent tissue-destructive agent. Consequently, appropriate formulation selection and comprehensive patient counseling are paramount to maximizing its clinical efficacy while mitigating the significant risks of local skin irritation and, in cases of excessive use or improper application, systemic toxicity (salicylism).[5]
Section 1: Identification and Physicochemical Profile
This section establishes the fundamental chemical identity of salicylic acid, providing a comprehensive reference for its properties. This foundational data is crucial for understanding its formulation, stability, and pharmacokinetic behavior.
1.1. Nomenclature and Chemical Identifiers
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/02/06 | Phase 4 | Completed | Vichy Laboratoires | ||
2015/02/02 | Phase 2 | Completed | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2014/05/30 | Phase 2 | UNKNOWN | |||
2013/08/02 | Phase 2 | Completed | |||
2009/02/18 | Phase 2 | Completed | |||
2006/08/08 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Jiangxi Hemei Pharmaceutical Co., Ltd | 84010-183 | TOPICAL | 17 g in 100 g | 9/19/2025 | |
| Rida LLC | 83004-026 | TOPICAL | 3 g in 100 mL | 5/28/2025 | |
| Shenzhen Yangan Technology Co., Ltd. | 84023-115 | TOPICAL | 1 mg in 100 mL | 3/24/2025 | |
| Vitamex USA, Corp | 69469-017 | TOPICAL | 170 mg in 1 mL | 6/23/2025 | |
| Kenvue Brands LLC | 69968-0908 | TOPICAL | 20 mg in 1 mL | 8/20/2025 | |
| Summers Laboratories Inc | 11086-043 | TOPICAL | 6 g in 92.6 mL | 10/9/2023 | |
| Elorac, Inc. | 42783-323 | TOPICAL | 285 mg in 1 mL | 8/8/2016 | |
| Dickinson Brands Inc. | 52651-048 | TOPICAL | 0.032 g in 1.58 mL | 4/10/2025 | |
| SANSAR, LLC | 83691-009 | TOPICAL | 12 g in 100 g | 5/7/2025 | |
| Jiangxi Hemei Pharmaceutical Co., Ltd | 84010-141 | TOPICAL | 40 g in 100 1 | 7/7/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PINEAPPLE BRAND LOTION | SIN16082P | LOTION | 10% w/v | 1/19/2021 | |
| SAW HONG CHOON SKIN OINTMENT | SIN09830P | OINTMENT | 5% w/w | 6/18/1998 | |
| CENTA SKIN LOTION 2% w/v | SIN04701P | LOTION | 2% w/v | 6/12/1990 | |
| BETACYLIC OINTMENT | SIN15211P | OINTMENT | 30mg/g | 4/12/2017 | |
| SALICYLIC ACID 2% CREAM | SIN02882P | CREAM | 2% w/w | 5/22/1989 | |
| NIXODERM OINTMENT | SIN04418P | OINTMENT | 2.50% w/w | 5/3/1990 | |
| Collomack Salicylic Acid Solution 10% | SIN13728P | SOLUTION | 100mg | 11/12/2009 | |
| TOH SKIN OINTMENT 5% w/w | ICM PHARMA PTE. LTD. | SIN07382P | OINTMENT | 5% w/w | 4/5/1993 |
| ICM WHITE SPOT LOTION 5% | SIN09177P | LOTION | 5% w/v | 1/24/1997 | |
| COCOIS CO. OINTMENT | SIN03627P | OINTMENT | 2% w/w | 7/24/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DERMACORN FOOT SOAKING POWDER | N/A | N/A | N/A | 7/14/2011 | |
| RADISOL ACID SALICYLIC APPLICATION | N/A | N/A | N/A | 1/24/1979 | |
| SUSIK POWDER | N/A | N/A | N/A | 7/3/1998 | |
| NIZO SPRAY | N/A | N/A | N/A | 1/29/2001 | |
| CURCYTOL SKIN LOTION (SPRAY) | N/A | N/A | N/A | 2/11/1998 | |
| WHITASALIC OINTMENT | N/A | N/A | N/A | 2/16/1994 | |
| DECADOID CORN PLASTER 10% | N/A | ming tai pharmaceuticals company o/b sure brilliant industrial limited | N/A | N/A | 8/21/2009 |
| PHENADERM SPRAY | N/A | N/A | N/A | 5/27/1988 | |
| CORN MATE PLASTER 10% | N/A | ming tai pharmaceuticals company o/b sure brilliant industrial limited | N/A | N/A | 3/8/2010 |
| MAGIC POWDER | N/A | N/A | N/A | 10/14/2007 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SM 33 ADULT FORMULA LIQUID paint bottle | 12181 | Pharmaco Australia Ltd | Medicine | A | 8/9/1991 |
| COCO-SCALP coal tar solution 12% w/w, salicylic acid 2% w/w and sulfur-precipitated 4% w/w ointment tube | 206327 | Medicine | A | 2/22/2013 | |
| ACTIKERALL fluorouracil and salicylic acid 0.5% / 10% (w/w) topical solution, bottle | 287446 | Medicine | A | 8/15/2019 | |
| JOHN PLUNKETT'S SUPERFADE SKIN CREAM tube | 341504 | Medicine | A | 8/13/2020 | |
| JOHN PLUNKETT'S SUNSPOT CREAM salicylic acid 50 mg/g jar | 11630 | Medicine | A | 9/12/1991 | |
| DUOFILM solution bottle | 14820 | Medicine | A | 9/12/1991 | |
| JOHN PLUNKETT'S PSOR-ASIST CREAM jar | 11628 | Medicine | A | 9/12/1991 | |
| SCHOLL WART REMOVAL SYSTEM salicylic acid 400mg/g medicated dressing sachet | 53606 | Medicine | A | 9/29/1995 | |
| WART-OFF PAINT bottle | 18915 | Pharmacare Laboratories Pty Ltd | Medicine | A | 9/30/1991 |
| Dr Michaels Scalp & Body Cleansing Gel | 281182 | Medicine | A | 10/10/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SOLUVER ENFANTS/KIDS | dermtek pharma inc | 02245445 | Solution - Topical | 17 % | 7/30/2002 |
| SALICYLIC ACID SOAP 3.5% | stiefel canada ulc | 00187542 | Soap Bar - Topical | 3.5 % | 12/31/1966 |
| MEDICATED CALLUS REMOVERS | pittsburgh plastics manufacturing | 02248118 | Disc - Topical | 40 % | 12/23/2003 |
| THERAPRO EXFOLIATING DANDRUFF TREATMENT SHAMPOO | canmax laboratories inc. | 02237050 | Liquid - Topical | 1.8 % | N/A |
| ACNEX LIQ 2% | dermtek pharma inc | 00685186 | Liquid - Topical | 2 % | 12/31/1987 |
| CLEARASIL CLEANSER - LIQ 2% | procter & gamble inc | 02220741 | Liquid - Topical | 2 % | 7/7/1997 |
| DERMA CONTROLE: GEL NETTOYANT MOUSSANT | yves rocher inc. | 02202417 | Gel - Topical | .5 % | 12/31/1996 |
| ACNE STICK GEL | tp health ltd. | 02238787 | Gel - Topical | 0.5 % | N/A |
| CLEARASIL STAYCLEAR ZONE CONTROL CLEARSTICK | procter & gamble inc | 02238910 | Liquid - Topical | 2 % | N/A |
| VITALGINE STAM | produits francais labs inc. | 00166308 | Liquid - Oral | 17.745 MG / 30 G | 12/31/1930 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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