AQUASOL A Parenteral

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: AQUASOL A Parenteral
Generic name: WATER-MISCIBLE RETINYL PALMITATE
Manufacturer: Rising Pharma Holdings, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 1abd66eb-6ac8-4a9e-a609-251e46ea1a27
SPL ID: 0c90883f-68ce-459d-8239-4e96e0b49c80
Version: 1
Effective date: 2026-03-03
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:47:12

Harmonized routes table
Harmonized routes
INTRAMUSCULAR

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	006823	derived:openfda.application_number
application number		NDA006823	openfda.application_number
brand name		AQUASOL A Parenteral	openfda.brand_name
generic name		WATER-MISCIBLE RETINYL PALMITATE	openfda.generic_name
manufacturer name		Rising Pharma Holdings, Inc.	openfda.manufacturer_name
ndc	package	64980-721-02	openfda.package_ndc
ndc	product	64980-721	openfda.product_ndc
ndc11	package	64980072102	derived:openfda.package_ndc
rxcui		210972	openfda.rxcui
rxcui		313650	openfda.rxcui
spl id		0c90883f-68ce-459d-8239-4e96e0b49c80	id
spl set id		1abd66eb-6ac8-4a9e-a609-251e46ea1a27	set_id
unii		1D1K0N0VVC	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 Avoid overdosage. Keep out of the reach of children. Pediatric Use: Polysorbates have been associated with E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis) in low birthweight infants.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS See OVERDOSAGE section. Anaphylactic shock and death have been reported using the intravenous route. Allergic reactions have been reported rarely with administration of AQUASOL A ® Parenteral including one case of an anaphylactoid type reaction. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 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.