Overview
Zinc sulfate is the inorganic compound with the formula ZnSO4 and historically known as "white vitriol". It is on the World Health Organization's List of Essential Medicines, a list of the most important medication needed in a basic health system.
Indication
This medication is a mineral used to treat or prevent low levels of zinc alone and together with oral rehydration therapy (ORT). It is also used as a topical astringent. Zinc Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for TPN.
Associated Conditions
- Dry Eyes
- Local itching
- Localized pain
- Localized swelling
Research Report
A Comprehensive Monograph on Zinc Sulfate (DB09322): From Essential Micronutrient to Pharmacological Agent
Section 1: Identification and Physicochemical Characteristics
Zinc sulfate is an inorganic compound with a long history in both chemistry and medicine, where it was historically known as "white vitriol" or "white copperas".[1] As a modern therapeutic agent, it is a small molecule drug recognized by DrugBank with the accession number DB09322.[1] Its primary role is to serve as a source of zinc, an essential trace element vital for numerous physiological processes. This section provides a detailed profile of its chemical and physical properties, which are fundamental to understanding its formulation, stability, and clinical application.
1.1. Nomenclature and Chemical Identity
For unambiguous identification in scientific, regulatory, and clinical contexts, zinc sulfate is defined by a set of standardized identifiers.
- Primary Name: Zinc sulfate [1]
- DrugBank Accession: DB09322 [1]
- Drug Modality: Small Molecule [1]
- CAS Number: The Chemical Abstracts Service (CAS) number for the anhydrous form is 7733-02-0.[1] The heptahydrate form is also identified by CAS number 7446-20-0, a distinction relevant for chemical sourcing and manufacturing.[6]
- Synonyms: The compound is referred to by several names, including zinc sulphate, zinc sulfate anhydrous, and zinc sulphate anhydrous.[1]
- Common Brand Names: In clinical practice, zinc sulfate is available under various brand names, including Anodan-HC, Anusol, Egozinc, Multitrace-4, Multitrace-5, Orazinc, Zinc-220, and others.[1]
- Regulatory Identifiers: Key chemical identifiers include:
- IUPAC Name: zinc; sulfate [10]
- EC Number: 231-793-3 [10]
- UNII: 89DS0H96TB [11]
1.2. Chemical Structure and Properties
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/05 | Not Applicable | Recruiting | Quaid-e-Azam Medical College | ||
2025/03/25 | Phase 3 | Completed | |||
2024/08/19 | Phase 2 | Recruiting | |||
2024/08/16 | Not Applicable | Completed | dr. Aldora Jesslyn Oentari | ||
2024/07/24 | Phase 4 | Not yet recruiting | Amira Adel Fouly | ||
2024/07/01 | Phase 2 | Completed | |||
2024/05/30 | Phase 3 | Not yet recruiting | |||
2022/05/27 | Phase 2 | UNKNOWN | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2022/04/05 | Phase 4 | Completed | Zekai Tahir Burak Women's Health Research and Education Hospital | ||
2021/12/17 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Fresenius Kabi USA, LLC | 65219-403 | INTRAVENOUS | 3 mg in 1 mL | 12/12/2022 | |
Zydus Pharmaceuticals USA Inc. | 70710-1877 | INTRAVENOUS | 3 mg in 1 mL | 8/31/2023 | |
PureTek Corporation | 59088-112 | ORAL | 18.2 mg in 1 1 | 1/11/2023 | |
Discount Drug Mart, Inc. | 53943-490 | OPHTHALMIC | 0.25 g in 100 mL | 1/1/2024 | |
American Regent, Inc. | 0517-6103 | INTRAVENOUS | 3 mg in 1 mL | 10/1/2020 | |
Piramal Critical Care Inc. | 66794-239 | INTRAVENOUS | 25 mg in 5 mL | 12/21/2023 | |
Zydus Pharmaceuticals USA Inc. | 70710-1878 | INTRAVENOUS | 5 mg in 1 mL | 8/31/2023 | |
Zydus Lifesciences Limited | 70771-1849 | INTRAVENOUS | 3 mg in 1 mL | 8/31/2023 | |
Gland Pharma Limited | 68083-608 | INTRAVENOUS | 1 mg in 1 mL | 9/7/2023 | |
Fresenius Kabi USA, LLC | 65219-401 | INTRAVENOUS | 1 mg in 1 mL | 12/12/2022 |
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 |
---|---|---|---|---|---|
SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION | SIN16135P | INJECTION, EMULSION | 0.0066g/1000ml | 3/24/2021 |
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 |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
METAGENICS ZINC DRINK | 64051 | Medicine | A | 4/27/1998 | |
MOUTH ULCER | 343446 | Medicine | A | 9/14/2020 | |
Kids Immunity Boost | 456171 | Medicine | A | 7/24/2024 | |
Recoverthol | 291026 | Medicine | A | 7/5/2017 | |
HOPEPLUS PEAK FORMULA FOR YOU TRIBULUS TERRESTRIS LIQUID oral liquid bottle | 74818 | C & W International Development (Holding) Pty Ltd | Medicine | A | 6/14/2000 |
OPTHALMIC LABS ZINC SULFATE 50mg/1mL Injection | 22857 | Medicine | A | 10/14/1991 | |
Conceive Plus Women's Fertility Support | 347979 | Medicine | A | 11/11/2020 | |
Frequent Flyer Immunity Boost | 406538 | Medicine | A | 3/21/2023 | |
NRGY Sports Relief | 129942 | ProSports Nutrition Pty Ltd | Medicine | A | 8/2/2006 |
Frequent Flyer Immunity Boost (Raspberry Flavour) | 410130 | Medicine | A | 6/6/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ZINCUM SULFURICUM | dolisos canada inc. | 02234804 | Granules
,
Globules
,
Liquid - Oral | 3 X | 1/5/1998 |
HEMORRHOIDAL OINTMENT WITH ANESTHETIC FOR EXTRA PAIN RELIEF | cellchem pharmaceuticals inc. | 02295865 | Ointment - Rectal | 0.5 % / W/W | N/A |
ALLERGY EYE DROPS | juno otc inc | 02290596 | Solution - Ophthalmic | 0.25 % / W/V | 5/23/2007 |
ANUSOL-HC OINTMENT | church & dwight canada corp | 00505773 | Ointment - Rectal | 0.5 % | 12/31/1981 |
VISINE A.C. OPHTHALMIC SOL | pfizer canada inc., consumer healthcare division | 01942433 | Liquid - Ophthalmic | .25 % | 12/31/1981 |
ZINCUM SULFURICUM GRANULE (3DH-30DH) | homeocan inc. | 01955160 | Tablet - Oral | 3 DH / TAB | 12/31/1991 |
ZINCUM SULFURICUM-INJEEL LIQ (10D,30D,200D/1.1ML) | 02051370 | Liquid - Oral | 10 D / 1.1 ML | 12/31/1993 | |
RECTOGEL HC | laboratoire riva inc. | 00662461 | Ointment - Rectal | 0.5 % | 5/26/1998 |
MULTI VITAMIN MINERAL TAB | nutristar health products (1987) inc. | 00474800 | Tablet - Oral | 1.5 MG / TAB | 12/31/1979 |
ANUSOL PLUS OINTMENT | church & dwight canada corp | 01945912 | Ointment - Rectal
,
Topical | 0.5 % | 12/31/1992 |
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. |
Help Us Improve
Your feedback helps us provide better drug information and insights.