FDA.reportPublic FDA data

Mineral Oil

Product NDC
55301-831
11-digit product format
553010831
Labeler code
55301
Product ID
55301-831_5a1db1ec-0e59-3044-e063-6294a90ab03e
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
LIQUID
Route
ORAL; TOPICAL
Labeler
Your Military Exchanges
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-05
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
6025dce6-02e8-418c-a248-0b5c33ff6067Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-831-43Mineral Oil473 mL in 1 BOTTLE, PLASTICLIQUID47314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-831MINERAL OIL LIQUID [YOUR MILITARY EXCHANGES]12Current NDC, Legacy NDC, 1 package rows20250331_6025dce6-02e8-418c-a248-0b5c33ff6067.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 23 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDEH E Bab995d9a-1e40-2b38-e053-2a95a90a87e42025-08-21WarningsExact identifier
application number: M007
SenokotSTANDARDIZED SENNA CONCENTRATEAtlantis Consumer Healthcare, Inc.d5bf67e5-82c6-edbf-e9ec-e027fdd47c842025-08-20WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)330758d2-fc1a-50ce-e063-6294a90a7db12025-08-19WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMAmerican Health Packaging4b84d5d7-43cf-47bb-af59-088550c3a0bc2025-08-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMGood Sense (Geiss, Destin & Dunn, Inc.)8066a52d-e683-47c1-905c-290d2d427acf2025-08-12WarningsExact identifier
application number: M007
ProlaxaDOCUSATE SODIUM 250MGAdvanced Rx of Tennessee, LLC3ba0c0d9-9e6f-a2e6-e063-6394a90a202d2025-08-05WarningsExact identifier
application number: M007
Dulcolax Stool SoftenerDOCUSATE SODIUMChattem, Inc.86cb7102-3585-4757-9c37-5bf9776bbe632025-08-01WarningsExact identifier
application number: M007
LEADER Mineral OilMINERAL OILCardinal Health, 110 dba Leader7d4f8fa3-8203-5523-e053-2991aa0aba1a2025-07-28WarningsExact identifier
application number: M007
Rapidol Sal InglesaMAGNESIUM SULFATE HEPTAHYDRATEPharmadel LLC1d4ef5f0-54c5-4838-e063-6394a90a44a82025-07-28WarningsExact identifier
application number: M007
Enemeez KidsDOCUSATE SODIUMQuest Products LLCf1602ba4-ad02-2936-e053-2995a90a27f22025-07-15WarningsExact identifier
application number: M007
SennosidesSENNOSIDESBryant Ranch Prepackd4ab04e4-b78a-4afc-aa16-d9dc8fb6cc102025-07-14WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTStrategic Sourcing Services LLC1515fadd-a7a5-4502-afe2-cfcd50d5bfc82025-07-11WarningsExact identifier
application number: M007
Quality Choice Fiber CapletsCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)29dbc831-23c1-487d-902a-9404d9ebe8052025-07-09WarningsExact identifier
application number: M007
Rexall Ready to use 4pk LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMDolgencorp, LLC78509915-0ef1-4238-99a5-78a49a68f98f2025-07-07WarningsExact identifier
application number: M007
Sal Inglesa EPSOM SALTMAGNESIUM SULFATE HEPTAHYDRATEMenper Distributors, Inc247aa3a3-d38f-4799-b44d-dfe18324fd0c2025-07-01WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMChain Drug Consortium, LLC550000ba-0d6d-4666-8461-f591c14478b12025-06-27WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEChain Drug Consortium, LLCc9807e6e-9dcc-41a2-8956-b61623ac21762025-06-27WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMChain Drug Consortium, LLC09449649-fd57-4446-8264-6c3bdd6621d02025-06-27WarningsExact identifier
application number: M007
SennaSENNOSIDESBryant Ranch Prepackf2b14378-2b60-4533-b232-8c8647fbce782025-06-26WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET CORPORATION28fce2e2-2101-df88-e063-6394a90aa3de2025-06-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705909mineral oil 99.9 % Oral SolutionPSN6025dce6-02e8-418c-a248-0b5c33ff606714
705909mineral oil 999 MG/ML Oral SolutionSCD6025dce6-02e8-418c-a248-0b5c33ff606714
705909mineral oil 99.9 % Oral SolutionSY6025dce6-02e8-418c-a248-0b5c33ff606714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-831-4355301083143473 mL in 1 BOTTLE, PLASTIC (55301-831-43) 473 ml2015-06-050000-00-00NoNoCurrent