POTASSIUM CHLORIDE
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- POTASSIUM CHLORIDE
- Generic name
- POTASSIUM CHLORIDE
- Manufacturer
- Aurobindo Pharma Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- b17d54ca-5885-48d3-96e9-b29ad14f8d76
- SPL ID
- b17d54ca-5885-48d3-96e9-b29ad14f8d76
- Version
- 1
- Effective date
- 2025-11-24
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:16:55
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 216536 | derived:openfda.application_number |
| application number | ANDA216536 | openfda.application_number | |
| brand name | POTASSIUM CHLORIDE | openfda.brand_name | |
| generic name | POTASSIUM CHLORIDE | openfda.generic_name | |
| manufacturer name | Aurobindo Pharma Limited | openfda.manufacturer_name | |
| ndc | package | 59651-959-47 | openfda.package_ndc |
| ndc | package | 59651-960-47 | openfda.package_ndc |
| ndc | product | 59651-960 | openfda.product_ndc |
| ndc | product | 59651-959 | openfda.product_ndc |
| ndc11 | package | 59651096047 | derived:openfda.package_ndc |
| ndc11 | package | 59651095947 | derived:openfda.package_ndc |
| rxcui | 314182 | openfda.rxcui | |
| rxcui | 312515 | openfda.rxcui | |
| spl id | b17d54ca-5885-48d3-96e9-b29ad14f8d76 | id | |
| spl set id | b17d54ca-5885-48d3-96e9-b29ad14f8d76 | set_id | |
| unii | 660YQ98I10 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
5 WARNINGS AND PRECAUTIONS Gastrointestinal Irritation: Dilute before use, take with meals ( 5.1 ) 5.1 Gastrointestinal Irritation May cause gastrointestinal irritation if administered undiluted. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [ see Dosage and Administration (2.1) ].
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
6 ADVERSE REACTIONS The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.