FDA.reportPublic FDA data

Mineral Oil

Product NDC
36800-334
11-digit product format
368000334
Labeler code
36800
Product ID
36800-334_b3d9996c-e3e5-432a-a4bb-32c7fb2aeaad
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
OIL
Route
ORAL; TOPICAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-11-30
Marketing end
2027-12-28
Substance
MINERAL OIL
Active strength
100 mg/100mL
NDC exclude flag
No
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
Mineral Oil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL100 mg/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-334-16Mineral Oil473 mL in 1 BOTTLE, PLASTICOIL4738

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-334MINERAL OIL OIL [TOP CARE (TOPCO ASSOCIATES LLC)]8Current NDC, Legacy NDC, 1 package rows20250426_0dd5380e-9671-4a2b-a2ce-6477503d06d2.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 20 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
up and up fiber therapyPSYLLIUM HUSKTarget Corporation674753ee-1174-4c06-9ed3-a090b338a39e2025-11-05WarningsExact identifier
application number: M007
up and up fiber therapyPSYLLIUM HUSKTARGET CORPORATION956c48f8-c705-4a86-9866-c68a48ddeb6c2025-11-05WarningsExact identifier
application number: M007
CEO-TWOLAXATIVEBeutlich Pharmaceuticals, LLC08670636-5795-4db0-e063-6294a90afa4b2025-11-05WarningsExact identifier
application number: M007
up and up gentle laxativeBISACODYLTarget Corporation4a29dc2b-b68f-471b-a84e-4a5096aa37482025-11-04WarningsExact identifier
application number: M007
Target Fiber LaxativePSYLLIUM HUSKTARGET CORPORATIONa581116a-392d-4ac3-ae15-4318506a7b2a2025-11-04WarningsExact identifier
application number: M007
up and up fiber therapyCALCIUM POLYCARBOPHILTarget Corporation.e5473950-06f4-4ea4-975b-3ac94957e7762025-11-04WarningsExact identifier
application number: M007
up and up fiber therapy Natural FiberPSYLLIUM HUSKTarget Corporationf8b1c831-6fd0-4a58-9726-4e0f986c80842025-11-04WarningsExact identifier
application number: M007
OneLAXBISACODYLAKRON PHARMA INCbe4eeb4d-df29-45dc-94ff-933e52c8b6f62025-11-03WarningsExact identifier
application number: M007
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY169b33f9-e559-47bf-bbba-c7eda4762c7f2025-10-31WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESWalgreens765bfd9b-7a21-4315-9add-cf13007722d52025-10-31WarningsExact identifier
application number: M007
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY71b15339-2585-4fae-8445-6fbb4f0a378e2025-10-31WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals97561cd4-63d9-44c2-a3a3-ec668a09a4ed2025-10-31WarningsExact identifier
application number: M007
Fiber CapletsCALCIUM POLYCARBOPHILSAFEWAY08e2e8b0-90b3-48d6-a72a-40688c74771a2025-10-29WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.424d91f0-ecf9-6d9b-e063-6394a90a80062025-10-29WarningsExact identifier
application number: M007
Publix Laxative Maximum StrengthCALCIUM SENNOSIDESPUBLIX SUPER MARKETS, INC11112859-ef1e-4b37-9915-ba4d06a3f1982025-10-28WarningsExact identifier
application number: M007
Publix Stimulant LaxativeBISACODYLPUBLIX SUPER MARKETS, INC02e596a7-b8e5-4f55-9bc6-6d17e0fabda72025-10-28WarningsExact identifier
application number: M007
PUBLIXPSYLLIUM HUSKPUBLIX SUPER MARKETS, INC55f98d3f-f282-4f19-b373-0b59640d274d2025-10-28WarningsExact identifier
application number: M007
PUBLIXCALCIUM POLYCARBOPHILPUBLIX SUPER MARKETS, INC02e3f4ce-8961-425c-98a9-3b9d66709ca52025-10-28WarningsExact identifier
application number: M007
Publix Women LaxativeBISACODYLPUBLIX SUPER MARKETS, INC03eeca55-f239-4a01-a900-c1943f27a8342025-10-28WarningsExact identifier
application number: M007
Publix Fiber Therapy Orange SmoothPSYLLIUM HUSKPUBLIX SUPER MARKETS, INCb9c54c20-cd82-4627-9217-a66834db47992025-10-28WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-334-1636800033416473 mL in 1 BOTTLE, PLASTIC (36800-334-16) 473 ml2016-11-302027-12-28NoNoCurrent