FDA.reportPublic FDA data

4718 Enema, Mineral Oil

Product NDC
67777-430
11-digit product format
677770430
Labeler code
67777
Product ID
67777-430_27596c71-a1ec-2f3c-e063-6394a90a8d6d
Type
HUMAN OTC DRUG
Nonproprietary name
4718 Enema, Mineral Oil
Dosage form
ENEMA
Route
RECTAL
Labeler
Dynarex
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-26
Substance
MINERAL OIL
Active strength
133 g/133mL
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
4718 Enema, Mineral Oil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL133 g/133mL

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
9e51c852-9477-5cf5-e053-2a95a90a97dbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-430-014718 Enema, Mineral Oil48 in 1 CASEENEMA483
67777-430-024718 Enema, Mineral Oil133 mL in 1 BOTTLEENEMA1333
67777-430-024718 Enema, Mineral Oil1 in 1 BOXENEMA13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-4304718 ENEMA, MINERAL OIL ENEMA [DYNAREX]3Current NDC, Legacy NDC, 3 package rows20241122_9e51c852-9477-5cf5-e053-2a95a90a97db.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 35 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant FreeCALCIUM POLYCARBOPHILAmerisourcebergen Drug Corporation4911fb44-e070-46c1-8f90-b78ceb10e51e2024-06-28WarningsExact identifier
application number: M007
FleetDOCUSATE SODIUMC.B. Fleet Company, Inc.56a7b6c5-d674-4eed-91c2-77f7d18fff322024-06-27WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMWALMART INC. (see also Equate)2cf6c9bf-c318-445d-9306-5675b1d424b02024-06-26WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWALMART INC. (see also Equate)d9db24b5-e3b5-47f9-b86b-bc8d70896a112024-06-26WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE CALCIUMWalgreens2791223a-7ac0-47e5-9a6a-4d9a02cfeb632024-06-25WarningsExact identifier
application number: M007
FleetBISACODYLC.B. Fleet Company, Inc.4e0d973f-e6dc-48d9-8df3-1d47c87840f12024-06-21WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESTOP CARE (Topco Associates LLC)3b184800-649b-45d0-9586-8055d6d7fe082024-06-20WarningsExact identifier
application number: M007
Senna LaxativeSENNA LAXATIVEGood Sense9393032e-4343-4ac5-8e91-36013e5ca0892024-06-18WarningsExact identifier
application number: M007
Stool SoftenerSTOOL SOFTENERGood Sense64266195-1b07-42c2-98a7-d76c12f747762024-06-18WarningsExact identifier
application number: M007
Stool Softener Plus StimulantDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI6c8c7c46-3ded-4e89-8e16-30eeb72aa08b2024-06-14WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI50ca1ce2-885f-4b71-a5fb-90c2cf508ce62024-06-14WarningsExact identifier
application number: M007
basic care stool softenerDOCUSATE SODIUMAmazon.com Services LLC356a889f-ec23-4eb2-a25c-bbe6094751552024-06-14WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFI88cc2575-27a1-4514-bc41-bd1eac2838142024-06-13WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFI2b5e1f03-0182-4d1c-8ba0-b1008b1335ad2024-06-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation1b7edd67-7b14-4fdd-9821-637f4b3c3a2c2024-06-06WarningsExact identifier
application number: M007
SennaSENNOSIDESPatrin Pharma, Inc.a9f1ef8d-8700-481f-a709-972bb9d271532024-05-30WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWALGREEN COMPANY5f9cd233-6c46-5b52-e053-2991aa0ab7292024-05-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFIb1d903a5-1d5f-44d4-9939-a4b86e5a620d2024-05-23WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFI30b9bbf3-0a64-41de-bfb4-5c8c257cc3e82024-05-23WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEMEIJER, INC.11fe5bd0-585a-ad8a-e063-6294a90a3ae82024-05-22WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205121mineral oil 100 % EnemaPSN9e51c852-9477-5cf5-e053-2a95a90a97db3
205121mineral oil 1000 MG/ML EnemaSCD9e51c852-9477-5cf5-e053-2a95a90a97db3
205121mineral oil 100 % EnemaSY9e51c852-9477-5cf5-e053-2a95a90a97db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-430-016777704300148 BOX in 1 CASE (67777-430-01) / 1 BOTTLE in 1 BOX (67777-430-02) / 133 mL in 1 BOTTLE48 box2021-02-260000-00-00NoNoCurrent
67777-430-0267777043002133 mL in 1 BOTTLE133 mlHistorical