FDA.reportPublic FDA data

FLEET

Product NDC
0132-0400
11-digit product format
001320400
Labeler code
0132
Product ID
0132-0400_5dcf8e06-ec5f-a9b2-e063-6294a90a89b6
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
LIQUID
Route
ORAL
Labeler
C.B. Fleet Company, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-01
Marketing end
2027-02-28
Substance
MINERAL OIL
Active strength
2.5 g/5mL
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
FLEET
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL2.5 g/5mL

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
1489229Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0b7acab-add4-4daf-b1df-bb7cf5ca8e19Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0400-48FLEET480 mL in 1 BOTTLELIQUID4801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0400FLEET (MINERAL OIL) LIQUID [C.B. FLEET COMPANY, INC.]1Current NDC, 1 package rows20240405_e0b7acab-add4-4daf-b1df-bb7cf5ca8e19.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 10 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEFamily Dollar Stores, Inccc97cfb5-cd40-4589-942a-5bee611a28122026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEFamily Dollar Stores, Inc0ac1896d-7ed9-44e5-bf07-1478262372732026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILChain Drug Marketing Association4a003bb1-425d-cd97-e063-6294a90a5dda2026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEBetter Living Brands, LLCd8176ef6-cc68-4185-b5eb-e887562f6aaa2026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEBetter Living Brands, LLC07732845-c9ce-47bb-8b63-36a3d5ddf8b72026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
stimulant laxativeBISACODYLBIONPHARMA INC.4b1f7db3-c6a8-7f6a-e063-6394a90a58292026-02-22WarningsExact identifier
application number: M007
Castor OilCASTOR OILNice-Pak Products, LLCff6c8022-9522-4eae-b8ff-994ee37fba062026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILPerrigo Direct, Inc09e32476-1c60-4f1e-a51c-5fab2e744b302026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEPerrigo Direct, Inc22991685-8228-41e1-a13e-f57961e8dd0e2026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEPerrigo Direct, Inc24478279-9a11-4e12-956d-57dc7debf9412026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.3b8eae67-9e27-46bd-ab2b-02c719786bab2026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILMeijer, Inc.c4d03837-193b-4817-8b78-fbdfb9122f192026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.2070a4a6-7968-49f2-84ec-53bd1cd824452026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx LLCd148be81-79b4-41f7-b8d8-a0e85b6615922026-02-18WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATETarget Corporationa8e52a22-7c30-40c0-8f78-523775743bfb2026-02-18Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsExact identifier
application number: M007
CVS PharmacySALINE LAXATIVECVS Pharmacyedd58c52-18de-4ec4-aec3-44f3e17607a72026-02-17WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489229mineral oil 2.5 mL in 5 mL Oral SuspensionPSNe0b7acab-add4-4daf-b1df-bb7cf5ca8e191
1489229mineral oil 0.5 ML/ML Oral SuspensionSCDe0b7acab-add4-4daf-b1df-bb7cf5ca8e191
1489229mineral oil 2.5 ML per 5 ML Oral SuspensionSYe0b7acab-add4-4daf-b1df-bb7cf5ca8e191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0132-0400-4800132040048480 mL in 1 BOTTLE (0132-0400-48) 480 ml2024-04-012027-02-28NoNoCurrent