Sodium Citrate and Citric Acid

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: Sodium Citrate and Citric Acid
Generic name: SODIUM CITRATE AND CITRIC ACID MONOHYDRATE
Manufacturer: American Health Packaging
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 58fa9952-c8ab-4ebb-a073-15cc45f4832a
SPL ID: 1d62bd0d-9703-cbc0-e063-6294a90a7eea
Version: 1
Effective date: 2024-07-16
Source export date: 2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:56:30

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 · 22 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Sodium Citrate and Citric Acid	openfda.brand_name
generic name		SODIUM CITRATE AND CITRIC ACID MONOHYDRATE	openfda.generic_name
manufacturer name		American Health Packaging	openfda.manufacturer_name
ndc	package	60687-834-76	openfda.package_ndc
ndc	package	60687-832-16	openfda.package_ndc
ndc	package	60687-832-50	openfda.package_ndc
ndc	package	60687-834-45	openfda.package_ndc
ndc	package	60687-832-44	openfda.package_ndc
ndc	package	60687-834-51	openfda.package_ndc
ndc	product	60687-834	openfda.product_ndc
ndc	product	60687-832	openfda.product_ndc
ndc11	package	60687083244	derived:openfda.package_ndc
ndc11	package	60687083476	derived:openfda.package_ndc
ndc11	package	60687083216	derived:openfda.package_ndc
ndc11	package	60687083445	derived:openfda.package_ndc
ndc11	package	60687083250	derived:openfda.package_ndc
ndc11	package	60687083451	derived:openfda.package_ndc
rxcui		543014	openfda.rxcui
spl id		1d62bd0d-9703-cbc0-e063-6294a90a7eea	id
spl set id		58fa9952-c8ab-4ebb-a073-15cc45f4832a	set_id
unii		1Q73Q2JULR	openfda.unii
unii		XF417D3PSL	openfda.unii

Adverse reactions cross-check#

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

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

adverse reactions

ADVERSE REACTIONS Sodium Citrate and Citric Acid Oral Solution USP is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia. To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 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.