FDA.reportPublic FDA data

Oxytocin

Manufacturer
Cantrell Drug Company
Effective date
2014-12-11
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:20:20

Label at a glance#

ProductOxytocin
Active ingredientOXYTOCIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYTOCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3124a9ec-4142-06dc-5b1b-5c28cd8ea2fbProduct name220180829
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52533-170-302020-01-31C16284748780-19d75b9d0-9259-f424-e053-dadaa90a57ceOxytocin 30 USP Units Added to 5% Dextrose 500 mL Bag

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52533-170-30Oxytocin500 mL in 1 BAGINJECTION, SOLUTION5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52533-170OXYTOCIN INJECTION, SOLUTION [CANTRELL DRUG COMPANY]3Legacy NDC, 1 package rows20150226_89156ba1-931f-4f3f-ab8a-b1b63e9e4c63.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OXYTOCINACTIVE INGREDIENT1JQS135EYN3
OXYTOCINACTIVE MOIETY1JQS135EYN3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W23
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52533-17052533-170-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYTOCIN1JQS135EYNACTIB
DEXTROSEIY9XDZ35W2IACT
WATER059QF0KO0RIACT
ACETIC ACIDQ40Q9N063PCNTM
SODIUM HYDROXIDE55X04QC32ICNTM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DEXTROSEDEXTROSEIY9XDZ35W2CONCENTRATE / ORAL400 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2PASTILLE / ORAL826 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2LOZENGE / BUCCALNAExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET / ORAL183.66 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SOLUTION / INTRAVENOUS5.05 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRAVENOUS51.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, EXTENDED RELEASE / ORAL103.95 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, COATED / ORAL132 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SYRUP / ORAL620 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TROCHE / ORAL903.5 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2POWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SPRAY, METERED / NASAL50 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, CHEWABLE / ORAL1286 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET / SUBLINGUAL115.78 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2POWDER / VAGINAL430 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRASPINAL75 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRATHECAL1925 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SOLUTION / ORAL2489 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
494203c0-7b4f-474f-9582-048d148d65f489156ba1-931f-4f3f-ab8a-b1b63e9e4c632014-12-11Exact identifier
spl id: 494203c0-7b4f-474f-9582-048d148d65f4
spl set id: 89156ba1-931f-4f3f-ab8a-b1b63e9e4c63

Reported adverse events (FAERS/openFDA)#

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