FDA.reportPublic FDA data

Mineral Oil

Product NDC
72476-877
11-digit product format
724760877
Labeler code
72476
Product ID
72476-877_4a2c1352-7f09-01f6-e063-6394a90aeb76
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
LIQUID
Route
ORAL; TOPICAL
Labeler
Retail Business Services, LLC�
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-09
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
b0abcdf9-c226-424f-8970-c2135708c6c8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-877-43Mineral Oil473 mL in 1 BOTTLE, PLASTICLIQUID4737

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-877MINERAL OIL LIQUID [RETAIL BUSINESS SERVICES]5Current NDC, Legacy NDC, 1 package rows20240907_b0abcdf9-c226-424f-8970-c2135708c6c8.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 24 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FleetBISACODYLC.B. Fleet Company, Inc.324e61eb-8f6b-48d7-85c2-b1b5642691c92025-06-23WarningsExact identifier
application number: M007
Saline LaxativeSODIUM PHOSPHATEWalgreen Companyfb260df0-7bda-4299-84a5-44c8f94477982025-06-18WarningsExact identifier
application number: M007
De La Cruz Castor OilCASTOR OILDLC Laboratories, Inc.22fbad2e-e9fa-46ba-8617-ad79483cbe9a2025-06-13WarningsExact identifier
application number: M007
ProlaxaDOCUSATE SODIUM 250MGTerrain Pharmaceuticals32610e42-f352-09fd-e063-6394a90abff62025-06-12WarningsExact identifier
application number: M007
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGVillage Pharma29102014-9b0e-4899-958d-83111f94a6122025-06-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPower Health, Products, Inc.364b558b-69b5-bfa4-e063-6294a90acd0c2025-05-29WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPower Health, Products, Inc.364bc4f5-6337-6c89-e063-6394a90a12ab2025-05-29WarningsExact identifier
application number: M007
SENNASENNOSIDESAARNA USA INC.364d4dfc-a089-1a27-e063-6394a90ad77b2025-05-29WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEPower Health, Products, Inc.3634b4e4-4fea-9428-e063-6394a90a6ad92025-05-28WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEATLANTIC BIOLOGICALS CORP.30fb7b5e-56a3-423e-ae57-432006b54fff2025-05-23WarningsExact identifier
application number: M007
Senna LiquidSENNA LIQUIDBelleview Biosciences35d5f217-b101-3cd8-e063-6394a90adccd2025-05-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens816c82f8-0fa5-4b22-a226-e8f22f3eaa1d2025-05-23WarningsExact identifier
application number: M007
Senna LaxativeSENNAPD-Rx Pharmaceuticals, Inc.2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa2025-05-21WarningsExact identifier
application number: M007
SennaSENNOSIDESAkron Pharma Inc.55ce3969-d7a6-49c4-8c13-d95690efc1a62025-05-16WarningsExact identifier
application number: M007
Saline EnemaSODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASICDynarex Corporation7c7b68af-4ef2-4f84-9279-9f7a91c8d9c52025-05-14WarningsExact identifier
application number: M007
BisacodylBISACODYLRising Pharma Holdings, Inc.03429da4-1ce9-4789-bf54-ce1b3215b0132025-05-13WarningsExact identifier
application number: M007
COLACE EXTRA STRENGTH STOOL SOFTNERDOCUSATE SODIUMAtlantis Consumer Healthcare Inc.34e06b05-64a5-4b3e-af38-cdcd7c1d521b2025-05-01WarningsExact identifier
application number: M007
SennaSENNOSIDESPAI Holdings, LLC dba PAI Pharma7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed2025-04-28WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMBelleview Bio Science335f41d7-5c22-7c17-e063-6294a90a8f282025-04-22WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAmerican Health Packaginge5028f6d-d33d-47a9-8453-00af5cdf59a62025-04-20WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705909mineral oil 99.9 % Oral SolutionPSNb0abcdf9-c226-424f-8970-c2135708c6c87
705909mineral oil 999 MG/ML Oral SolutionSCDb0abcdf9-c226-424f-8970-c2135708c6c87
705909mineral oil 99.9 % Oral SolutionSYb0abcdf9-c226-424f-8970-c2135708c6c87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72476-877-4372476087743473 mL in 1 BOTTLE, PLASTIC (72476-877-43) 473 ml2018-07-090000-00-00NoNoCurrent