FDA.reportPublic FDA data

Enema Mineral Oil

Product NDC
67234-019
Requested package NDC
67234-019-01
11-digit product format
672340019
Labeler code
67234
Product ID
67234-019_93c3aa6d-aa45-4a56-84f5-6876db5b2572
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
ENEMA
Route
RECTAL
Labeler
Natureplex LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-01-05
Marketing end
0000-00-00
Substance
MINERAL OIL
Active strength
118 g/118mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67234-01967234-019-01IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-019-01Enema Mineral Oil133 mL in 1 BOTTLE, WITH APPLICATORENEMA1335
67234-019-01Enema Mineral Oil1 in 1 CARTONENEMA15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mineral OilACTIVE INGREDIENTT5L8T28FGPENEMA MINERAL OIL (MINERAL OIL) ENEMA [NATUREPLEX LLC]1
Mineral OilACTIVE MOIETYT5L8T28FGPENEMA MINERAL OIL (MINERAL OIL) ENEMA [NATUREPLEX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-019ENEMA MINERAL OIL (MINERAL OIL) ENEMA [NATUREPLEX LLC]5Legacy NDC, 2 package rows20250101_44ded8db-cace-416a-a15f-921fcdaa11bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205121mineral oil 100 % EnemaPSN44ded8db-cace-416a-a15f-921fcdaa11bd5
205121mineral oil 1000 MG/ML EnemaSCD44ded8db-cace-416a-a15f-921fcdaa11bd5
205121mineral oil 100 % EnemaSY44ded8db-cace-416a-a15f-921fcdaa11bd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67234-019-01672340019011 BOTTLE, WITH APPLICATOR in 1 CARTON (67234-019-01) > 133 mL in 1 BOTTLE, WITH APPLICATOR2013-01-050000-00-00NoNoCurrent