FDA.reportPublic FDA data

Castor Oil

Product NDC
36800-952
11-digit product format
368000952
Labeler code
36800
Product ID
36800-952_4ab7da71-af9e-7c32-e063-6394a90a7ced
Type
HUMAN OTC DRUG
Nonproprietary name
Castor Oil
Dosage form
LIQUID
Route
ORAL
Labeler
Topco Associates LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-09-15
Substance
CASTOR OIL
Active strength
1 g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct36800-952IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage36800-95236800-952-26IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CASTOR OIL1 g/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204691Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5643f2e0-93e2-4c2e-90a0-fd152150d18aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-06-23Top Care 078.000/078AA Castor Oil
2020-06-23Top Care 078.000/078AA Castor Oil
2020-01-31Top Care 078.000/078AA Castor Oil
2020-01-31Top Care 078.000/078AA Castor Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-952-26Castor Oil118 mL in 1 BOTTLE, PLASTICLIQUID11827

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CASTOR OILACTIVE INGREDIENTD5340Y2I9GCASTOR OIL LIQUID [TOPCO ASSOCIATES LLC]1
CASTOR OILACTIVE MOIETYD5340Y2I9GCASTOR OIL LIQUID [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-952CASTOR OIL LIQUID [TOPCO ASSOCIATES LLC]24Current NDC, Legacy NDC, 1 package rows20240731_5643f2e0-93e2-4c2e-90a0-fd152150d18a.zip

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 27 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BisacodylBISACODYL SUPPOSITORIESOncor Pharmaceuticals6f0aefc9-cd5f-4bdd-89c2-b6a80558987c2025-01-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.2c65319f-6cf5-aa90-e063-6394a90ad6622025-01-23WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECardinal Health (Leader) 70000cde87f95-73c0-46f5-9349-37e04096048c2025-01-22WarningsExact identifier
application number: M007
Senna-TabsSENNA 8.6MGUlai Health LLC485129a0-8340-4f61-be51-5abff5032b8d2025-01-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILTopco Associates, LLC0609468d-ee66-49af-be40-e51965b88f6f2025-01-20WarningsExact identifier
application number: M007
Soluble FiberMETHYLCELLULOSEUnited Natural Foods, Inc. dba UNFI6decd5ef-e8e1-44ae-8465-6266cf18e81e2025-01-20WarningsExact identifier
application number: M007
PerdiemSENNOSIDES, STIMULANT LAXATIVEHaleon US Holdings LLC6b256c8f-3953-4c69-9a16-ffa0511bdbcd2025-01-16WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESEverpharm LLC0ea9f2b5-4533-4b71-b019-10ecb3c064592025-01-16WarningsExact identifier
application number: M007
Anecream 5LIDOCAINE 5%Focus Health Group1810edc3-093e-402f-bcb0-9c731da283a72025-01-15WarningsExact identifier
application number: M007
SennaSENNOSIDESReliable 1 Laboratories LLCae46a611-20f2-74c8-e053-2995a90a32ce2025-01-15WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMReliable-1 Laboratories LLCa97a1829-f62f-2014-e053-2a95a90a8cc52025-01-15WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs4d678da0-9ada-4d00-9db9-33b45c7761072025-01-15WarningsExact identifier
application number: M007
Goodsense Fiber laxative 147CALCIUM POLYCARBOPHILGoodSense17f5570b-be85-9dce-e063-6294a90abeaf2025-01-14WarningsExact identifier
application number: M007
Sunmark Mineral Oil LaxativeMINERAL OILStrategic Sourcing Servicesc54f7df2-3845-425f-b13e-3dc000123f3c2025-01-14WarningsExact identifier
application number: M007
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGUlai Health LLCc0e27b02-8ef2-4239-8f8c-790f7d978dc02025-01-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals1541ff5b-11f8-444b-a2a0-8e3086ae650a2025-01-10WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAvPAKf31a4349-7826-45c0-9388-6b938d167b7a2025-01-09WarningsExact identifier
application number: M007
Docusate sodiumDOCUSATE SODIUMAPNAR PHARMA LP05b0732b-012f-78ee-e063-6294a90a839a2025-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMMcKessone5fdfcfd-5340-4929-9f68-2696110cca8e2025-01-07WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILSHANDONG XINHUA PHARMACEUTICAL CO., LTD.ee06868b-f741-8da2-e053-2a95a90a97722025-01-02WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204691castor oil 100 % Oral SolutionPSN5643f2e0-93e2-4c2e-90a0-fd152150d18a27
204691castor oil 1000 MG/ML Oral SolutionSCD5643f2e0-93e2-4c2e-90a0-fd152150d18a27
204691castor oil 100 % Oral SolutionSY5643f2e0-93e2-4c2e-90a0-fd152150d18a27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-952-2636800095226118 mL in 1 BOTTLE, PLASTIC (36800-952-26) 118 ml1991-09-150000-00-00NoNoCurrent