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 15 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Gentle LaxativeBISACODYLCVS Pharmacy0cca1516-fc8d-4471-bd37-a6230fd225e22026-01-14WarningsExact identifier
application number: M007
Rite-Aid Gentle LaxativeBISACODYLRITE AID PHARMACY0fb853db-8d97-64d6-e063-6294a90abeb52026-01-14WarningsExact identifier
application number: M007
Rite-Aid Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fb8f488-3386-29b9-e063-6294a90a014c2026-01-14WarningsExact identifier
application number: M007
Rite-Aid Childrens Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fbe4dfd-1d5d-fc31-e063-6394a90ab3172026-01-14WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMTOP CARE (Topco Associates LLC)92659389-c36f-499b-b284-5b520e50e9a62026-01-14WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESAVPAKaf75d33f-b081-4b9d-bc12-d2829fa1f0cf2026-01-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)597d2e9c-1adb-4c7d-ada3-de5c2db69c742026-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Mineral oil LaxativeMINERAL OILStrategic Sourcing Services LLCea6da66c-6825-4cd7-8791-45b537bf203a2026-01-08WarningsExact identifier
application number: M007
Sunmark Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC06720229-7d58-499e-b7de-cb4bda5ae4162026-01-08WarningsExact identifier
application number: M007
HealthMart Mineral Oil Single LaxativeMINERAL OILStrategic Sourcing Services LLC1238ec69-1ea3-4773-9f13-71f0ae0a35532026-01-08WarningsExact identifier
application number: M007
HealthMart Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC689228de-1f3e-4205-853d-6004d62488572026-01-08WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyc445864f-fc88-4885-9f40-d189b9dc42902026-01-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFIc46a1f7c-12e3-4be1-b9e4-d3edac0f43862026-01-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTOP CARE (Topco Associates LLC)44fe6ce0-5fed-418f-8a6a-d6132e2883282026-01-07WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMStrategic Sourcing Services LLC24e29f00-f1cf-4e92-bd67-3f6f820af7832026-01-07WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLC33000a06-e030-433a-8f9c-7ae5c08037fa2026-01-06WarningsExact identifier
application number: M007
Stool Softener Regular StrengthDOCUSATE SODIUMSam's West, Inc1eca5910-b0bf-4e07-8211-36dba52b3de72026-01-06WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEMajor Pharmaceuticalsc3d14605-fdec-49fc-b0ee-d4c3ae5f42b52026-01-05WarningsExact identifier
application number: M007
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUMLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c2025-12-31WarningsExact 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