FDA.reportPublic FDA data

FLEET

Product NDC
0132-0301
11-digit product format
001320301
Labeler code
0132
Product ID
0132-0301_749b7e47-7344-44ec-a526-0c7dc18680f2
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
ENEMA
Route
RECTAL
Labeler
C.B. Fleet Company, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-05-01
Substance
MINERAL OIL
Active strength
100 g/100mL
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 OIL100 g/100mL

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
205121Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2528cb5e-437e-41f0-9c34-e9ce57404d8bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0301-40FLEET133 mL in 1 BOTTLE, WITH APPLICATORENEMA13314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0132-0301-40ML - Milliliter0132-0301ddd6b765-e996-404e-96e9-5abb457fe06412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mineral OilACTIVE INGREDIENTT5L8T28FGPFLEET (MINERAL OIL) ENEMA [C.B. FLEET COMPANY, INC.]8
Mineral OilACTIVE MOIETYT5L8T28FGPFLEET (MINERAL OIL) ENEMA [C.B. FLEET COMPANY, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0301FLEET (MINERAL OIL) ENEMA [C.B. FLEET COMPANY, INC.]14Current NDC, Legacy NDC, 1 package rows20231025_2528cb5e-437e-41f0-9c34-e9ce57404d8b.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 28 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Laxative Docusate Sodium with SennaDOCUSATE SODIUM AND SENNOSIDESTOPCO ASSOCIATES LLCcf9075d8-e20e-419a-b996-9b12f49f05f22025-01-01WarningsExact identifier
application number: M007
Vegetable Laxative and Stool SoftnerDOCUSATE SODIUM AND SENNOSIDESTOPCO ASSOCIATES LLCe84d693d-0041-4c11-8f6a-b5c332f79af92025-01-01WarningsExact identifier
application number: M007
AcetaminophenEXTRA STRENGTH PAIN RELIEFNuCare Pharmaceuticals,Inc.a32f346e-71d0-cc11-e053-2a95a90ae88c2024-12-31WarningsExact identifier
application number: M007
LaxacinDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx Pharmacy of Tennessee, LLCfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2024-12-31WarningsExact identifier
application number: M007
NATUREPLEX Enema(SALINE)Natureplex, LLC0bd6d0a8-33e5-40be-a6c6-33fea92b11dd2024-12-31WarningsExact identifier
application number: M007
Magnesium CitrateCVS MAGNESIUM CITRATE ORAL SOLUTION - LEMONCVS Pharmacy, Inc.fb7f9b67-ff0e-3af4-e053-6294a90ac5392024-12-30WarningsExact identifier
application number: M007
Magnesium CitrateCVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPECVS Pharmacy, Inc.fb808dc5-bf80-836c-e053-6294a90a80aa2024-12-30WarningsExact identifier
application number: M007
Magnesium CitrateCVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRYCVS Pharmacy, Inc.fb80ffce-a7b6-7f19-e053-6294a90a5c6b2024-12-30WarningsExact identifier
application number: M007
Foster and Thrive Castor OilCASTOR OILStrategic Sourcing Services, LLC004d1dc2-47c1-84d1-e063-6394a90a24712024-12-30WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMA-S Medication Solutions946abcdb-96bd-43e6-992a-bb97679c00f02024-12-30WarningsExact identifier
application number: M007
HEB Maximum strength Laxative pillsSENNOSIDESH E B86e5dff5-91e6-47a5-8f3c-b1e86adfc1f42024-12-26WarningsExact identifier
application number: M007
Equaline Regular Strength Chocolated Stimulant LaxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFIe9200d63-a0d1-4f68-bb5e-7507c46cf8002024-12-26WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEWALGREEN COMPANYeffad954-b70d-d8e6-e053-2a95a90acaf72024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEWALGREEN COMPANYeffad365-d76e-71af-e053-2995a90aa0202024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEWALGREEN COMPANYeffaeff6-c48b-1558-e053-2995a90ab52f2024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATESTRATEGIC SOURCING SERVICESf9e1291a-f64d-2431-e053-6394a90a35f12024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEAMERISOURCE BERGENf384094e-c4d2-3882-e053-2995a90a77942024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEAMERISOURCE BERGENf3847b0f-802d-73d7-e053-2a95a90a5bbe2024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATESTRATEGIC SOURCING SERVICESf9e1291a-f650-2431-e053-6394a90a35f12024-12-23WarningsExact identifier
application number: M007
Leader Regular Strength Chocolate Laxative sennosidesSENNOSIDESCARDINAL HEALTH1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e2024-12-23WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205121mineral oil 100 % EnemaPSN2528cb5e-437e-41f0-9c34-e9ce57404d8b14
205121mineral oil 1000 MG/ML EnemaSCD2528cb5e-437e-41f0-9c34-e9ce57404d8b14
205121mineral oil 100 % EnemaSY2528cb5e-437e-41f0-9c34-e9ce57404d8b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0132-0301-4000132030140133 mL in 1 BOTTLE, WITH APPLICATOR (0132-0301-40) 133 ml2002-05-010000-00-00NoNoCurrent