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: ANI Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 0128a879-7185-4b70-b0bb-d108ff1c9542
SPL ID: 0128a879-7185-4b70-b0bb-d108ff1c9542
Version: 1
Effective date: 2023-07-20
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:37:03

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	212816	derived:openfda.application_number
application number		ANDA212816	openfda.application_number
brand name		Potassium chloride	openfda.brand_name
generic name		POTASSIUM CHLORIDE	openfda.generic_name
manufacturer name		ANI Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	70954-197-10	openfda.package_ndc
ndc	package	70954-197-30	openfda.package_ndc
ndc	package	70954-197-20	openfda.package_ndc
ndc	product	70954-197	openfda.product_ndc
ndc11	package	70954019730	derived:openfda.package_ndc
ndc11	package	70954019720	derived:openfda.package_ndc
ndc11	package	70954019710	derived:openfda.package_ndc
rxcui		1867544	openfda.rxcui
spl id		0128a879-7185-4b70-b0bb-d108ff1c9542	id
spl set id		0128a879-7185-4b70-b0bb-d108ff1c9542	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. 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. To report SUSPECTED ADVERSE REACTIONS, contact Novitium Pharma LLC at 1-855-204-1431 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.