FDA.reportPublic FDA data

HealthMart Mineral Oil Single

Product NDC
62011-0270
11-digit product format
620110270
Labeler code
62011
Product ID
62011-0270_5aba4ed6-733e-41b3-8a79-1ef10cf4447b
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
ENEMA
Route
RECTAL
Labeler
Strategic Sourcing Services LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-05-10
Substance
MINERAL OIL
Active strength
118 g/118mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
HealthMart Mineral Oil Single
Brand name suffix
Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL118 g/118mL

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
1238ec69-1ea3-4773-9f13-71f0ae0a3553Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-02-04HealthMart ® Mineral Oil Enema Single Laxative
2020-02-04HealthMart ® Mineral Oil Enema Single Laxative
2020-01-31HealthMart ® Mineral Oil Enema Single Laxative
2020-01-31HealthMart ® Mineral Oil Enema Single Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0270-1HealthMart Mineral Oil SingleLaxative1 in 1 CARTONENEMA15
62011-0270-1HealthMart Mineral Oil SingleLaxative133 mL in 1 BOTTLEENEMA1335

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0270-1ML - Milliliter62011-02706dff9fc0-f16c-4ad6-8a62-53e4bcd9642112016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0270HEALTHMART MINERAL OIL SINGLE LAXATIVE (MINERAL OIL) ENEMA [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20250101_1238ec69-1ea3-4773-9f13-71f0ae0a3553.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 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack2c9a1fe7-b77b-436b-8701-9f95f642d0012024-07-05WarningsExact identifier
application number: M007
SENNASENNAPrecision Dose, Inc.e637777e-a39d-4e2f-a95c-4f524aa122f72024-07-05WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEGERI-CARE PHARMACEUTICALS, CORP1c462af8-af1a-391c-e063-6394a90a8b492024-07-02WarningsExact identifier
application number: M007
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205121mineral oil 100 % EnemaPSN1238ec69-1ea3-4773-9f13-71f0ae0a35535
205121mineral oil 1000 MG/ML EnemaSCD1238ec69-1ea3-4773-9f13-71f0ae0a35535
205121mineral oil 100 % EnemaSY1238ec69-1ea3-4773-9f13-71f0ae0a35535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0270-1620110270011 BOTTLE in 1 CARTON (62011-0270-1) / 133 mL in 1 BOTTLE1 bottle2012-05-100000-00-00NoNoCurrent