Mineral oil

Product NDC
51316-831
11-digit product format
513160831
Labeler code
51316
Product ID
51316-831_5528eed0-1a93-0fd9-e063-6394a90a6e2e
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral oil
Dosage form
LIQUID
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-16
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
1183bcbc-51ec-e53a-e063-6394a90af0f2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-831-43Mineral oil473 mL in 1 BOTTLE, PLASTICLIQUID4733
51316-831-45Mineral oil946 mL in 1 BOTTLE, PLASTICLIQUID9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-831MINERAL OIL LIQUID [CVS PHARMACY]2Current NDC, 2 package rows20250326_1183bcbc-51ec-e53a-e063-6394a90af0f2.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 13 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATESam's West, Inc6edb7688-0a64-4a7e-a0c0-9f75c96682fe2026-02-03WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)cb2698b1-6c58-417f-ae86-74fbe38146262026-02-03WarningsExact identifier
application number: M007
Castor OilCASTOR OILCVS Pharmacy, Inc.f20de8f2-3637-4485-8b80-0a12fd5e651c2026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATECVS Pharmacy, Inc.1dca8f4a-f544-4ae5-bb0a-8b671d4a488a2026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATECVS Pharmacy, Inc.15a9996d-7391-41f8-ab15-27ee2a6a60e42026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATERite Aid Corporatione562bf42-b9e1-4ea8-b880-7bec4dd620b42026-01-30Warnings, Adverse reactionsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESStrategic Sourcing Services, LLC905bd658-a0af-4f20-be3d-00c54868a26c2026-01-29WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESStrategic Sourcing Services LLC9248a907-a8bd-47d5-98a2-48534d6023d42026-01-29WarningsExact identifier
application number: M007
Leader Castor OilCASTOR OILCardinal Health, 110 dba Leader49e3a40a-b717-43f6-abed-473d7ed03c2e2026-01-29Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILCARDINAL HEALTH 110, LLC. DBA LEADER803f444f-d136-4f06-9842-24a71a3d7d6b2026-01-29Warnings, Adverse reactionsExact identifier
application number: M007
Equate Ready-to-Use Enema LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMWalMart04c7440e-5b25-4b63-9604-321298d510212026-01-29WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMeijer Distribution Inc.81edf0d8-b6f3-4b3a-85db-0108160756b12026-01-28WarningsExact identifier
application number: M007
Quality Choice LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMChain Drug Marketing Association1cac3b6b-155b-47bb-bb79-17c55d3457362026-01-28WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED1ad73079-ebb3-dae7-e063-6294a90a05582026-01-28WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100MGDOCUSATE SODIUM 100MGFarmacias De Similares TX LLC44269b79-a5ad-f443-e063-6294a90a84732026-01-28WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED19830f9a-27b1-910d-e063-6294a90adace2026-01-27WarningsExact identifier
application number: M007
SennosidesSENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED94936bd4-8bbf-6211-e053-2995a90a21382026-01-27Exact identifier
application number: M007
SennosidesSENNOSIDESSoftgel Healthcare Pvt Ltd16582306-7321-6c7c-e063-6394a90a509e2026-01-27WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESWal-Mart Stores Inc97695092-1ded-4723-a015-fdadd7c28c812026-01-27WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILCVS Pharmacy, Incc3de1c1b-5042-aec3-e053-2a95a90ad1342026-01-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705909mineral oil 99.9 % Oral SolutionPSN1183bcbc-51ec-e53a-e063-6394a90af0f23
705909mineral oil 999 MG/ML Oral SolutionSCD1183bcbc-51ec-e53a-e063-6394a90af0f23
705909mineral oil 99.9 % Oral SolutionSY1183bcbc-51ec-e53a-e063-6394a90af0f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-831-4351316083143473 mL in 1 BOTTLE, PLASTIC (51316-831-43) 473 ml2024-02-16NoNoCurrent
51316-831-4551316083145946 mL in 1 BOTTLE, PLASTIC (51316-831-45) 946 ml2024-02-16NoNoCurrent