FDA.reportPublic FDA data

Castor Oil

Product NDC
69452-487
11-digit product format
694520487
Labeler code
69452
Product ID
69452-487_3f9728e8-c7a3-6cfb-e063-6394a90a8f1d
Type
HUMAN OTC DRUG
Nonproprietary name
Castor Oil
Dosage form
LIQUID
Route
ORAL
Labeler
BIONPHARMA INC.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-06
Substance
CASTOR OIL
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Castor Oil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CASTOR OIL1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D5340Y2I9GInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f9728e8-c7a2-6cfb-e063-6394a90a8f1dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-487-97Castor Oil177 mL in 1 BOTTLELIQUID1771

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 24 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FleetBISACODYLC.B. Fleet Company, Inc.324e61eb-8f6b-48d7-85c2-b1b5642691c92025-06-23WarningsExact identifier
application number: M007
Saline LaxativeSODIUM PHOSPHATEWalgreen Companyfb260df0-7bda-4299-84a5-44c8f94477982025-06-18WarningsExact identifier
application number: M007
De La Cruz Castor OilCASTOR OILDLC Laboratories, Inc.22fbad2e-e9fa-46ba-8617-ad79483cbe9a2025-06-13WarningsExact identifier
application number: M007
ProlaxaDOCUSATE SODIUM 250MGTerrain Pharmaceuticals32610e42-f352-09fd-e063-6394a90abff62025-06-12WarningsExact identifier
application number: M007
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGVillage Pharma29102014-9b0e-4899-958d-83111f94a6122025-06-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPower Health, Products, Inc.364b558b-69b5-bfa4-e063-6294a90acd0c2025-05-29WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPower Health, Products, Inc.364bc4f5-6337-6c89-e063-6394a90a12ab2025-05-29WarningsExact identifier
application number: M007
SENNASENNOSIDESAARNA USA INC.364d4dfc-a089-1a27-e063-6394a90ad77b2025-05-29WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEPower Health, Products, Inc.3634b4e4-4fea-9428-e063-6394a90a6ad92025-05-28WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEATLANTIC BIOLOGICALS CORP.30fb7b5e-56a3-423e-ae57-432006b54fff2025-05-23WarningsExact identifier
application number: M007
Senna LiquidSENNA LIQUIDBelleview Biosciences35d5f217-b101-3cd8-e063-6394a90adccd2025-05-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens816c82f8-0fa5-4b22-a226-e8f22f3eaa1d2025-05-23WarningsExact identifier
application number: M007
Senna LaxativeSENNAPD-Rx Pharmaceuticals, Inc.2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa2025-05-21WarningsExact identifier
application number: M007
SennaSENNOSIDESAkron Pharma Inc.55ce3969-d7a6-49c4-8c13-d95690efc1a62025-05-16WarningsExact identifier
application number: M007
Saline EnemaSODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASICDynarex Corporation7c7b68af-4ef2-4f84-9279-9f7a91c8d9c52025-05-14WarningsExact identifier
application number: M007
BisacodylBISACODYLRising Pharma Holdings, Inc.03429da4-1ce9-4789-bf54-ce1b3215b0132025-05-13WarningsExact identifier
application number: M007
COLACE EXTRA STRENGTH STOOL SOFTNERDOCUSATE SODIUMAtlantis Consumer Healthcare Inc.34e06b05-64a5-4b3e-af38-cdcd7c1d521b2025-05-01WarningsExact identifier
application number: M007
SennaSENNOSIDESPAI Holdings, LLC dba PAI Pharma7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed2025-04-28WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMBelleview Bio Science335f41d7-5c22-7c17-e063-6294a90a8f282025-04-22WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAmerican Health Packaginge5028f6d-d33d-47a9-8453-00af5cdf59a62025-04-20WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-487-9769452048797177 mL in 1 BOTTLE (69452-487-97) 177 ml2025-10-06NoNoCurrent