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 6 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature CareCASTORBetter Living Brands, LLC4947cf4d-3ebd-4b66-9582-f141407aa3002026-06-15Warnings, Adverse reactionsExact identifier
application number: M007
WALGREEN GLYCERIN ADULTGLYCERIN SUPPOSITORYWalgreens20c44346-0b29-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
application number: M007
WALGREENS GLYCERINGLYCERIN SUSPENSIONWalgreens20c44346-0b2b-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
application number: M007
Stratuscare BisacodylBISACODYLStratus Pharmaceuticals795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d2026-06-09WarningsExact identifier
application number: M007
LaxativeLAXATIVEAllegiant Health596b11de-cf17-4c55-8638-49f387e5fac42026-06-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)16691fd4-cdf3-41d4-b851-5fa148a054682026-06-08WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDECardinal Health 107, LLC144c7242-4ff9-404a-86bf-48e2871eb0cd2026-06-05WarningsExact identifier
application number: M007
Senna Natural VegetableSENNOSIDESMedline Industries, LP9a6240f3-398c-06b8-e053-2995a90a73df2026-06-04WarningsExact identifier
application number: M007
Senna SSENNOSIDES AND DOCUSATE SODIUMMedline Industries, LP6cd22881-db60-9045-e053-2991aa0ae08a2026-06-04WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.53727f3a-914c-0e2c-e063-6394a90a38862026-06-04WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEGeri-Care Pharmaceuticals, Corp99eb67ca-301c-dfdb-e053-2a95a90aff6f2026-05-28WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECVS PHARMACY, INC1f9e72dc-a394-420d-8fe8-fc4d0f6906ed2026-05-27WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy9983095a-6ef4-4ad7-acc5-e34221fb7c632026-05-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS PHARMACY, INC056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1382026-05-20WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDES 8.8MG/5MLAldama Pharmaceuticals, Inc491255c6-465f-a78a-e063-6394a90aa4082026-05-15WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMCardinal Health 107, LLC40385b89-a855-4ca2-992a-df5eb677be152026-05-15WarningsExact identifier
application number: M007
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticalscc8d1556-f108-4166-837c-48f81152877e2026-05-12WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEGOODSENSEa9509715-cc4f-595d-e053-2a95a90ae31f2026-05-11WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCee14dfe2-405f-493a-a774-ce1b01d05dd42026-05-05WarningsExact 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