FDA.reportPublic FDA data

Mineral Oil

Product NDC
41250-831
11-digit product format
412500831
Labeler code
41250
Product ID
41250-831_4b348794-a274-161f-e063-6394a90ab1a6
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
LIQUID
Route
ORAL; TOPICAL
Labeler
Meijer, Inc.
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
652d1da9-a71f-4113-9ef3-da0916724625Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-831-43Mineral Oil473 mL in 1 BOTTLE, PLASTICLIQUID47313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-831MINERAL OIL LIQUID [MEIJER DISTRIBUTION INC]12Current NDC, Legacy NDC, 1 package rows20250403_652d1da9-a71f-4113-9ef3-da0916724625.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 26 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Womens Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f2c4ed1a-5aa4-1915-e053-2a95a90a59b62025-02-12WarningsExact identifier
application number: M007
LaxativeSENNOSIDESBETTER LIVING BRANDS LLC.f2c5c1e6-3123-c802-e053-2995a90aa0732025-02-12WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESBETTER LIVING BRANDS LLC.f2c529e4-6738-377c-e053-2995a90aaf382025-02-12WarningsExact identifier
application number: M007
WOMENS GENTLE LAXATIVEBISACODYLCVS HEALTH CORPa95073f3-e1d6-d291-e053-2a95a90aefea2025-02-12WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVESENNOSIDESCVS HEALTHb05ee52f-4801-d4ca-e053-2995a90af3482025-02-12WarningsExact identifier
application number: M007
SENNASENNOSIDESReliable 1 Laboratories LLCc8aa7ae9-7d00-db7d-e053-2995a90ae72b2025-02-11WarningsExact identifier
application number: M007
Extra Gentle LaxativeBISACODYLDOLGENCORP INCbe214c4e-f6db-cc8d-e053-2a95a90addf72025-02-10WarningsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESKROGERa187045c-c9d6-592a-e053-2995a90adb832025-02-10WarningsExact identifier
application number: M007
SENNA TIMESENNOSIDESTIME CAP LABORATORIES, INC18ec8127-422c-4c1a-8331-58dabce699692025-02-08WarningsExact identifier
application number: M007
SENNA TIME SDOCUSATE SODIUM-SENNOSIDESTIME CAP LABORATORIES, INCdc491692-8d3a-4ccd-a17d-4c630f1225952025-02-08WarningsExact identifier
application number: M007
LAX-TIMESENNOSIDESTIME CAP LABORATORIES, INC74a627fc-00e5-eb78-e053-2991aa0abacc2025-02-08WarningsExact identifier
application number: M007
SENNOSIDES AND DOCUSATE SODIUMSENNOSIDES AND DOCUSATE SODIUMTIME CAP LABORATORIES, INC0ad617e0-10a6-44fa-be62-4f3cc725fb012025-02-08WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMAsclemed USA, Inc.2db546de-20dc-4697-aff2-12471f073b1d2025-02-08WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESTIME CAP LABORATORIES, INC7498f5fa-1739-bb6e-e053-2a91aa0a54042025-02-07WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEWALMART INC.26b9f247-c242-2925-e063-6394a90a68dd2025-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPAI Holdings, LLC dba PAI Pharmae975a3f1-0e1f-4fb8-9c5f-baa75e12f2a52025-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.6a7e4193-22d2-491e-9842-5c43f571fc652025-02-05WarningsExact identifier
application number: M007
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50MG SOFTGEL (RED)DOCUSATE SODIUMCVS Pharmacy273e5b52-1cf9-2525-e063-6394a90a8b4f2025-02-04WarningsExact identifier
application number: M007
LaxativeSENNOSIDESWALGREENSf0caba1d-0c09-8496-e053-2995a90a47cf2025-01-30WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705909mineral oil 99.9 % Oral SolutionPSN652d1da9-a71f-4113-9ef3-da091672462513
705909mineral oil 999 MG/ML Oral SolutionSCD652d1da9-a71f-4113-9ef3-da091672462513
705909mineral oil 99.9 % Oral SolutionSY652d1da9-a71f-4113-9ef3-da091672462513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-831-4341250083143473 mL in 1 BOTTLE, PLASTIC (41250-831-43) 473 ml2004-12-220000-00-00NoNoCurrent