Acetic 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: Acetic Acid
Generic name: ACETIC ACID
Manufacturer: Baxter Healthcare Corporation
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 41bc12af-fac5-4ac1-b907-dcb3e35a054c
SPL ID: 87782b03-c260-4e1d-b96e-8f5aa94411e2
Version: 13
Effective date: 2018-02-02
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 06:17:19

Harmonized routes table
Harmonized routes
IRRIGATION

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	018523	derived:openfda.application_number
application number		NDA018523	openfda.application_number
brand name		Acetic Acid	openfda.brand_name
generic name		ACETIC ACID	openfda.generic_name
manufacturer name		Baxter Healthcare Corporation	openfda.manufacturer_name
ndc	package	0338-0656-04	openfda.package_ndc
ndc	product	0338-0656	openfda.product_ndc
ndc11	package	00338065604	derived:openfda.package_ndc
rxcui		307707	openfda.rxcui
spl id		87782b03-c260-4e1d-b96e-8f5aa94411e2	id
spl set id		41bc12af-fac5-4ac1-b907-dcb3e35a054c	set_id
unii		Q40Q9N063P	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

WARNINGS Not for injection. Use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesion. Absorption via open lesions of the bladder mucosa may result in systemic acidosis. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Systemic acidosis, pain and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% Acetic Acid Irrigation, USP. Should adverse reactions occur, discontinue the irrigation and reevaluate the clinical status of the patient.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.