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 19 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.9019ae9e-da3e-4ed1-b83e-d9a6375e9c302025-11-25WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMFamily Dollar (FAMILY WELLNESS)d61ba4ef-5b03-4d29-b1fd-81591f0c8a2c2025-11-25WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM AND SENNOSIDESMarlex Pharmaceuticals Inc9c87759f-3856-4f30-b5ea-4b37ed90f18c2025-11-21WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMarlex Pharmaceuticals Inc5ca287a3-c4f6-402d-978e-cd1328bdbc472025-11-21WarningsExact identifier
application number: M007
SAMS WESTPSYLLIUM HUSKSAM'S WEST INC2aaf5d99-6d28-4fa6-b3c5-52dcfc94dac02025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corpbb47ad1f-251c-491e-8ddd-6f6f719efa152025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEChain Drug Marketing Association440a96bb-9e68-bdcc-e063-6294a90a67932025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEChain Drug Marketing Association4277b174-4ce5-4950-8e9b-75e3c019a8f32025-11-20WarningsExact identifier
application number: M007
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.c1677d70-203b-493e-88f0-815a66133f1d2025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5ea9237a-7895-388d-e053-2991aa0a92b02025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5ea9305b-2997-49d3-e053-2991aa0a1fa12025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDECVS3c8f5b69-56f2-4e9d-e054-00144ff88e882025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDECVS3cdf1975-2607-14f5-e054-00144ff8d46c2025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDERITE AID PHARMACY60284706-445f-f795-e053-2a91aa0a0a122025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp9f588e9b-56c5-4426-89fc-7b83e2d0ad1a2025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFact Productsaebbdd10-0650-6efe-e053-2a95a90a0ab22025-11-19WarningsExact identifier
application number: M007
Stool Softener with Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLC0cbe3b61-ce35-4be1-9caf-9c61fce10ca22025-11-17WarningsExact identifier
application number: M007
good sense stool softenerDOCUSATE SODIUML. Perrigo Company4658d162-6e62-4d84-b5d6-7bf16c9155582025-11-14WarningsExact identifier
application number: M007
Topco Fiber Therapy Sugar FreePSYLLIUM HUSKTOPCO ASSOCIATES LLC2c61e73e-b3f7-4ab2-8bda-e65a2c0b35602025-11-10WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILLEADER/ Cardinal Health 110, Inc.b4637e18-c65f-0e81-e053-2a95a90a22842025-11-06WarningsExact 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