pure and gentle

Generic: mineral oil

Labeler: medline industries, lp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pure and gentle
Generic Name mineral oil
Labeler medline industries, lp
Dosage Form ENEMA
Routes
RECTAL
Active Ingredients

mineral oil 100 g/100mL

Manufacturer
Medline Industries, LP

Identifiers & Regulatory

Product NDC 53329-013
Product ID 53329-013_27d437bf-4b2b-eb33-e063-6394a90a4ef6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M007
Listing Expiration 2026-12-31
Marketing Start 2014-04-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53329013
Hyphenated Format 53329-013

Supplemental Identifiers

RxCUI
205121
UNII
T5L8T28FGP

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pure and gentle (source: ndc)
Generic Name mineral oil (source: ndc)
Application Number M007 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 100 g/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (53329-013-11) / 133 mL in 1 BOTTLE
source: ndc

Packages (1)

53329-013-11 1 BOTTLE in 1 BOX (53329-013-11) / 133 mL in 1 BOTTLE

Ingredients (1)

mineral oil (100 g/100mL)

Linked Drug Pages (1)

Pure and Gentle ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "27d437bf-4b2b-eb33-e063-6394a90a4ef6", "openfda": {"unii": ["T5L8T28FGP"], "rxcui": ["205121"], "spl_set_id": ["96d4cad5-0602-4c31-94ed-3117b4fd4a94"], "manufacturer_name": ["Medline Industries, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (53329-013-11)  / 133 mL in 1 BOTTLE", "package_ndc": "53329-013-11", "marketing_start_date": "20140409"}], "brand_name": "Pure and Gentle", "product_id": "53329-013_27d437bf-4b2b-eb33-e063-6394a90a4ef6", "dosage_form": "ENEMA", "product_ndc": "53329-013", "generic_name": "mineral oil", "labeler_name": "Medline Industries, LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pure and Gentle", "active_ingredients": [{"name": "MINERAL OIL", "strength": "100 g/100mL"}], "application_number": "M007", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140409", "listing_expiration_date": "20261231"}