Home NDC 53329-013 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 Ingredient Strength MINERAL OIL 100 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T5L8T28FGP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205121 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-013-11 Pure and Gentle 1 in 1 BOX ENEMA 1 8 53329-013-11 Pure and Gentle 133 mL in 1 BOTTLE ENEMA 133 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-013 PURE AND GENTLE (MINERAL OIL) ENEMA [MEDLINE INDUSTRIES, LP] 8 Current NDC, Legacy NDC, 2 package rows 20241127_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 17 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-013-11 53329001311 1 BOTTLE in 1 BOX (53329-013-11) / 133 mL in 1 BOTTLE 1 bottle 2014-04-09 0000-00-00 No No Current