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 (canonical bytes are SHA-256 checked before publication)

Brand name: Potassium Chloride
Generic name: POTASSIUM CHLORIDE
Manufacturer: Amneal Pharmaceuticals NY LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 590dd25c-c4cb-489a-a09b-eccbf1d37c1f
SPL ID: db3a588c-7554-4b71-939b-277a6f037f25
Version: 12
Effective date: 2026-07-01
Source export date: 2026-10-12
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:16:54

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 24 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	210041	derived:openfda.application_number
application number		ANDA210041	openfda.application_number
brand name		Potassium Chloride	openfda.brand_name
generic name		POTASSIUM CHLORIDE	openfda.generic_name
manufacturer name		Amneal Pharmaceuticals NY LLC	openfda.manufacturer_name
ndc	package	69238-1458-4	openfda.package_ndc
ndc	package	69238-1459-4	openfda.package_ndc
ndc	package	69238-1459-2	openfda.package_ndc
ndc	package	69238-1458-2	openfda.package_ndc
ndc	package	69238-1458-3	openfda.package_ndc
ndc	package	69238-1459-3	openfda.package_ndc
ndc	product	69238-1459	openfda.product_ndc
ndc	product	69238-1458	openfda.product_ndc
ndc11	package	69238145804	derived:openfda.package_ndc
ndc11	package	69238145902	derived:openfda.package_ndc
ndc11	package	69238145803	derived:openfda.package_ndc
ndc11	package	69238145904	derived:openfda.package_ndc
ndc11	package	69238145802	derived:openfda.package_ndc
ndc11	package	69238145903	derived:openfda.package_ndc
rxcui		314182	openfda.rxcui
rxcui		312515	openfda.rxcui
spl id		db3a588c-7554-4b71-939b-277a6f037f25	id
spl set id		590dd25c-c4cb-489a-a09b-eccbf1d37c1f	set_id
unii		660YQ98I10	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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 Amneal Pharmaceuticals LLC at 1-877-835-5472 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.