FDA.reportPublic FDA data

Mineral Oil

Product NDC
36800-931
11-digit product format
368000931
Labeler code
36800
Product ID
36800-931_4ab9c8b7-a428-85ea-e063-6394a90a8b73
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
LIQUID
Route
ORAL; TOPICAL
Labeler
Topco Associates LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-12-22
Substance
MINERAL OIL
Active strength
999 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Mineral Oil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL999 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T5L8T28FGPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
705909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9b1fd61-c229-4529-82c2-d6ac5b076082Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-931-43Mineral Oil473 mL in 1 BOTTLE, PLASTICLIQUID47312

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-931MINERAL OIL LIQUID [TOPCO ASSOCIATES]10Current NDC, Legacy NDC, 1 package rows20240802_e9b1fd61-c229-4529-82c2-d6ac5b076082.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 7 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMCardinal Health 107, LLC1a21b07a-263c-41a4-ba0c-ad2dc5a295d72026-05-05WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED4842a767-bb12-9d85-e063-6294a90a19b52026-04-27WarningsExact identifier
application number: M007
Alcohol wet wipesALCOHOL WET WIPESShandong Aishule Hygiene Products Co., Ltdf79dbac0-cec0-46bc-e053-6294a90a2b132026-04-25WarningsExact identifier
application number: M007
Sterilized wet wipesSTERILIZED WET WIPESShandong Aishule Hygiene Products Co., Ltdf7ca1799-eee4-66f0-e053-6294a90a273f2026-04-25WarningsExact identifier
application number: M007
Wet wipesWET WIPESJINGXIN GROUP (M) SDN BHD395225b1-486b-1867-e063-6394a90a18652026-04-25WarningsExact identifier
application number: M007
Sterilized wet wipesSTERILIZED WET WIPESJINGXIN GROUP (M) SDN BHD3952873e-5e3f-1bff-e063-6294a90a8a622026-04-25WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMPublix Supermarkets, Inc.ed50555f-b105-45c8-9dc4-1bd4d233a1e32026-04-23WarningsExact identifier
application number: M007
Mineral OilMINERAL OILPublix Supermarkets, Inc.382a57d1-85bf-480f-9967-f85da29044102026-04-23WarningsExact identifier
application number: M007
BISACODYLBISACODYLAARNA USA INC.50109967-69af-5fc5-e063-6394a90a87512026-04-22WarningsExact identifier
application number: M007
SennaSENNARugby Laboratories41d53783-7ac2-411c-b9bf-afd87b3af30d2026-04-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFI95bae7bf-f240-4674-9e3c-640a603fdc352026-04-15WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPublix Super Markets, Inc.a4b442f1-d5a6-4cbf-b371-1f6639634f802026-04-13Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPublix Super Markets, Inc.267c434d-3034-491b-b4b1-1d0cbacb16152026-04-13Warnings, Adverse reactionsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackd616685a-11fc-4ae0-80de-7d25c0d71ee92026-04-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMH E B84116db2-a7b7-460a-a5e5-8558bd4247812026-04-02WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEAmerican Health Packaging7d7d789b-b2e7-4600-a025-0cd2ff5b36722026-04-02WarningsExact identifier
application number: M007
Castor OilCASTOR OILSTRATEGIC SOURCING SERVICES4db6736f-416a-f142-e063-6394a90ab08f2026-04-01WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEFarmacias De Similares TX LLC4e6a64a0-e453-709b-e063-6294a90a74432026-04-01WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals93ef6486-0930-41e3-a2c6-44af7e37e98b2026-03-31WarningsExact identifier
application number: M007
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack2c0d62e7-563b-46e4-9793-183e98e761a62026-03-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705909mineral oil 99.9 % Oral SolutionPSNe9b1fd61-c229-4529-82c2-d6ac5b07608212
705909mineral oil 999 MG/ML Oral SolutionSCDe9b1fd61-c229-4529-82c2-d6ac5b07608212
705909mineral oil 99.9 % Oral SolutionSYe9b1fd61-c229-4529-82c2-d6ac5b07608212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-931-4336800093143473 mL in 1 BOTTLE, PLASTIC (36800-931-43) 473 ml2004-12-220000-00-00NoNoCurrent