FDA.reportPublic FDA data

Mineral Oil

Product NDC
81033-042
11-digit product format
810330042
Labeler code
81033
Product ID
81033-042_30a11cc9-e408-23b7-e063-6294a90a7d6e
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-01
Substance
MINERAL OIL
Active strength
1000 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL1000 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
343017Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30a11cc9-e407-23b7-e063-6294a90a7d6eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-042-30Mineral Oil30 mL in 1 CUP, UNIT-DOSESOLUTION301
81033-042-50Mineral Oil50 in 1 CARTONSOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-042-30ML - Milliliter81033-042f0f21268-ce5c-4392-a927-75b9ade2ada212025-05-14
81033-042-50ML - Milliliter81033-0421c6d783f-55d6-4b91-9855-4721bcf9318d12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-042MINERAL OIL SOLUTION [KESIN PHARMA CORPORATION]1Current NDC, 2 package rows20250321_30a11cc9-e407-23b7-e063-6294a90a7d6e.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 20 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
up and up fiber therapyPSYLLIUM HUSKTarget Corporation674753ee-1174-4c06-9ed3-a090b338a39e2025-11-05WarningsExact identifier
application number: M007
up and up fiber therapyPSYLLIUM HUSKTARGET CORPORATION956c48f8-c705-4a86-9866-c68a48ddeb6c2025-11-05WarningsExact identifier
application number: M007
CEO-TWOLAXATIVEBeutlich Pharmaceuticals, LLC08670636-5795-4db0-e063-6294a90afa4b2025-11-05WarningsExact identifier
application number: M007
up and up gentle laxativeBISACODYLTarget Corporation4a29dc2b-b68f-471b-a84e-4a5096aa37482025-11-04WarningsExact identifier
application number: M007
Target Fiber LaxativePSYLLIUM HUSKTARGET CORPORATIONa581116a-392d-4ac3-ae15-4318506a7b2a2025-11-04WarningsExact identifier
application number: M007
up and up fiber therapyCALCIUM POLYCARBOPHILTarget Corporation.e5473950-06f4-4ea4-975b-3ac94957e7762025-11-04WarningsExact identifier
application number: M007
up and up fiber therapy Natural FiberPSYLLIUM HUSKTarget Corporationf8b1c831-6fd0-4a58-9726-4e0f986c80842025-11-04WarningsExact identifier
application number: M007
OneLAXBISACODYLAKRON PHARMA INCbe4eeb4d-df29-45dc-94ff-933e52c8b6f62025-11-03WarningsExact identifier
application number: M007
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY169b33f9-e559-47bf-bbba-c7eda4762c7f2025-10-31WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESWalgreens765bfd9b-7a21-4315-9add-cf13007722d52025-10-31WarningsExact identifier
application number: M007
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY71b15339-2585-4fae-8445-6fbb4f0a378e2025-10-31WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals97561cd4-63d9-44c2-a3a3-ec668a09a4ed2025-10-31WarningsExact identifier
application number: M007
Fiber CapletsCALCIUM POLYCARBOPHILSAFEWAY08e2e8b0-90b3-48d6-a72a-40688c74771a2025-10-29WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.424d91f0-ecf9-6d9b-e063-6394a90a80062025-10-29WarningsExact identifier
application number: M007
Publix Laxative Maximum StrengthCALCIUM SENNOSIDESPUBLIX SUPER MARKETS, INC11112859-ef1e-4b37-9915-ba4d06a3f1982025-10-28WarningsExact identifier
application number: M007
Publix Stimulant LaxativeBISACODYLPUBLIX SUPER MARKETS, INC02e596a7-b8e5-4f55-9bc6-6d17e0fabda72025-10-28WarningsExact identifier
application number: M007
PUBLIXPSYLLIUM HUSKPUBLIX SUPER MARKETS, INC55f98d3f-f282-4f19-b373-0b59640d274d2025-10-28WarningsExact identifier
application number: M007
PUBLIXCALCIUM POLYCARBOPHILPUBLIX SUPER MARKETS, INC02e3f4ce-8961-425c-98a9-3b9d66709ca52025-10-28WarningsExact identifier
application number: M007
Publix Women LaxativeBISACODYLPUBLIX SUPER MARKETS, INC03eeca55-f239-4a01-a900-c1943f27a8342025-10-28WarningsExact identifier
application number: M007
Publix Fiber Therapy Orange SmoothPSYLLIUM HUSKPUBLIX SUPER MARKETS, INCb9c54c20-cd82-4627-9217-a66834db47992025-10-28WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
343017mineral oil 100 % Oral SolutionPSN30a11cc9-e407-23b7-e063-6294a90a7d6e1
343017mineral oil 1000 MG/ML Oral SolutionSCD30a11cc9-e407-23b7-e063-6294a90a7d6e1
343017mineral oil 100 % Oral SolutionSY30a11cc9-e407-23b7-e063-6294a90a7d6e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-042-308103300423030 mL in 1 CUP, UNIT-DOSE30 mlHistorical
81033-042-508103300425050 CUP, UNIT-DOSE in 1 CARTON (81033-042-50) / 30 mL in 1 CUP, UNIT-DOSE (81033-042-30) 2025-03-01NoNoCurrent