FDA.reportPublic FDA data

Pure and Gentle

Product NDC
53329-013
11-digit product format
533290013
Labeler code
53329
Product ID
53329-013_27d437bf-4b2b-eb33-e063-6394a90a4ef6
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil
Dosage form
ENEMA
Route
RECTAL
Labeler
Medline Industries, LP
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-09
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
Pure and Gentle
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
96d4cad5-0602-4c31-94ed-3117b4fd4a94Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-013-11Pure and Gentle1 in 1 BOXENEMA18
53329-013-11Pure and Gentle133 mL in 1 BOTTLEENEMA1338

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-013-11ML - Milliliter53329-013b0d5e6df-8259-431e-8efb-0f526226206212022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPPURE AND GENTLE (MINERAL OIL) ENEMA [MEDLINE INDUSTRIES, INC.]2
MINERAL OILACTIVE MOIETYT5L8T28FGPPURE AND GENTLE (MINERAL OIL) ENEMA [MEDLINE INDUSTRIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-013PURE AND GENTLE (MINERAL OIL) ENEMA [MEDLINE INDUSTRIES, LP]8Current NDC, Legacy NDC, 2 package rows20241127_96d4cad5-0602-4c31-94ed-3117b4fd4a94.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 12 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Well at Walgreens Castor OilCASTOR OILWalgreen Co.e41f8553-3812-4d0b-95f8-20b2612792992026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEWalgreen Co.b5a02809-6e01-4e01-b1c3-2b10c5091a4e2026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILWalgreen Co.822fd02a-92b0-4010-8bfb-737dba331d542026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDERugby Laboratories5fd89979-903e-4b31-872d-3b8974af3a6b2026-02-09WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)1845ea0c-0cb6-482b-abe6-fa17785c5b902026-02-09WarningsExact identifier
application number: M007
Colace Fast-Acting Saline LaxativeMAGNESIUM HYDROXIDEAtlantis Consumer Healthcare, Inc.572adfaf-6e26-42e5-b65d-6d356a0bdfa92026-02-06WarningsExact identifier
application number: M007
Castor OilCASTOR OILRetail Business Services, LLC4e9c41fa-f240-4986-bb13-541bfeb0e50b2026-02-06WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATERetail Business Services, LLCf3661952-ef4f-4f29-93e6-ec09b84643652026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATERetail Business Services, LLC2f6e9f87-4bff-482b-a54f-f51ca99aac8c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATERetail Business Services, LLC1a8b540c-b66e-4dca-b7af-23705ae247b62026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILRetail Business Services, LLCb0abcdf9-c226-424f-8970-c2135708c6c82026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEPublix Super Markets, Inc.e985e071-5541-456e-ae4d-dba85287fe752026-02-05Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEDiscount Drug Marta82a4aa9-c8af-4383-9d92-ba6c596f00952026-02-04WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEDiscount Drug Martb05a94d2-5cc6-4989-9fb8-096e54fa78522026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEGrocery Outlet, Inc.3dff4b00-e71a-1dc0-e063-6394a90a715f2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEHARRIS TEETER73065a04-b7cd-437d-9624-f845f5ec93bf2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Harris TeeterMINERALHarris Teeter401e3a7e-54be-47cc-88c3-a343f5cbbd102026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEHy-Vee, Inc.45374a86-80a4-481c-e063-6294a90a381a2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEHy-Vee, Inc.44592ee0-13dd-57b1-e063-6394a90ab4022026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECVS Pharmacy, Inc.a78d991a-ba21-4bc4-b8f9-f8dafbddc28f2026-02-03Warnings, Adverse reactionsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205121mineral oil 100 % EnemaPSN96d4cad5-0602-4c31-94ed-3117b4fd4a948
205121mineral oil 1000 MG/ML EnemaSCD96d4cad5-0602-4c31-94ed-3117b4fd4a948
205121mineral oil 100 % EnemaSY96d4cad5-0602-4c31-94ed-3117b4fd4a948

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-013-11533290013111 BOTTLE in 1 BOX (53329-013-11) / 133 mL in 1 BOTTLE1 bottle2014-04-090000-00-00NoNoCurrent