Atropine Sulfate

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: Atropine Sulfate
Generic name: ATROPINE SULFATE
Manufacturer: Bausch & Lomb Incorporated
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: c0a56d60-0914-42b1-af59-c56afe93d18c
SPL ID: 72b36d2b-77a4-4b9e-b99d-99bf20e45cc5
Version: 8
Effective date: 2020-04-02
Source export date: 2026-10-27
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/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:12:27

Harmonized routes table
Harmonized routes
OPHTHALMIC

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Atropine Sulfate	openfda.brand_name
generic name		ATROPINE SULFATE	openfda.generic_name
manufacturer name		Bausch & Lomb Incorporated	openfda.manufacturer_name
ndc	package	24208-825-55	openfda.package_ndc
ndc	product	24208-825	openfda.product_ndc
ndc11	package	24208082555	derived:openfda.package_ndc
rxcui		1190570	openfda.rxcui
spl id		72b36d2b-77a4-4b9e-b99d-99bf20e45cc5	id
spl set id		c0a56d60-0914-42b1-af59-c56afe93d18c	set_id
unii		03J5ZE7KA5	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 In pediatric patients, use with extreme caution. Excessive use in pediatric patients or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning. If this occurs, discontinue medication and use appropriate therapy as outlined in OVERDOSAGE .

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in the very young. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 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.