FDA.reportPublic FDA data

Mineral Oil

Product NDC
48433-202
11-digit product format
484330202
Labeler code
48433
Product ID
48433-202_3d4d61f6-fa20-4a72-b7fd-2fdeb0709f5d
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
SOLUTION
Route
ORAL
Labeler
Safecor Health, LLC
Application
M334
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-01
Substance
MINERAL OIL
Active strength
1000 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
ef182484-692e-4eb3-bcf1-3c990ec0d08eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48433-202-302022-01-30C16284748780-1d6a99b39-8513-a426-e053-dadaa90af4c2SAFECOR HEALTH Mineral Oil USP 30 mL Unit Dose Drug Facts
48433-202-302022-01-28C16284748780-1d6a99b39-8513-a426-e053-dadaa90af4c2SAFECOR HEALTH Mineral Oil USP 30 mL Unit Dose Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-202-30Mineral Oil30 mL in 1 CUP, UNIT-DOSESOLUTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-202-30ML - Milliliter48433-20212bff3ec-94d8-4d44-ad4f-fa1c310a35b512019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48433-202MINERAL OIL SOLUTION [SAFECOR HEALTH, LLC]3Current NDC, Legacy NDC, 1 package rows20250110_ef182484-692e-4eb3-bcf1-3c990ec0d08e.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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCUSATE SODIUMDOCUSATE SODIUMSafecor Health, LLCefe4bf81-fb99-4755-aa23-4f8df5973be82025-01-08WarningsExact identifier
application number: M334
Mineral OilMINERAL OILSafecor Health, LLCef182484-692e-4eb3-bcf1-3c990ec0d08e2025-01-08WarningsExact identifier
application number: M334
ndc (product): 48433-202
Senna SyrupSENNOSIDESSafecor Health, LLCe1dca0d6-6e6e-4ba2-a7b8-009aeb00ef632025-01-08WarningsExact identifier
application number: M334

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
343017mineral oil 100 % Oral SolutionPSNef182484-692e-4eb3-bcf1-3c990ec0d08e3
343017mineral oil 1000 MG/ML Oral SolutionSCDef182484-692e-4eb3-bcf1-3c990ec0d08e3
343017mineral oil 100 % Oral SolutionSYef182484-692e-4eb3-bcf1-3c990ec0d08e3
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 startMarketing endSampleExclude flagStatus
48433-202-304843302023030 mL in 1 CUP, UNIT-DOSE (48433-202-30) 30 ml2014-10-010000-00-00NoNoCurrent