NDC 53329-013

Pure and Gentle

Mineral Oil

Pure and Gentle is a Rectal Enema in the Human Otc Drug category. It is labeled and distributed by Medline Industries, Inc.. The primary component is Mineral Oil.

Product ID53329-013_428a74ee-413b-093f-e054-00144ff8d46c
NDC53329-013
Product TypeHuman Otc Drug
Proprietary NamePure and Gentle
Generic NameMineral Oil
Dosage FormEnema
Route of AdministrationRECTAL
Marketing Start Date2014-04-09
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameMedline Industries, Inc.
Substance NameMINERAL OIL
Active Ingredient Strength100 g/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53329-013-11

1 BOTTLE in 1 BOX (53329-013-11) > 133 mL in 1 BOTTLE
Marketing Start Date2014-04-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53329-013-11 [53329001311]

Pure and Gentle ENEMA
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-04-09

Drug Details

Active Ingredients

IngredientStrength
MINERAL OIL100 g/100mL

OpenFDA Data

SPL SET ID:96d4cad5-0602-4c31-94ed-3117b4fd4a94
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205121

    • NDC Crossover Matching brand name "Pure and Gentle" or generic name "Mineral Oil"

    NDCBrand NameGeneric Name
    53329-013Pure and GentlePure and Gentle
    0132-0301FLEETMineral Oil
    0132-0556FLEETMineral Oil
    0395-1685Humco Mineral Oil HeavyMineral Oil
    0395-1673Humco Mineral Oil LightMineral Oil
    0363-0360Mineral OilMineral Oil
    0363-0831Mineral OilMineral Oil
    0363-0834Mineral OilMineral Oil
    0574-0618Mineral OilMineral Oil
    11673-034Mineral oilMineral oil
    11673-831Mineral OilMineral Oil
    11822-0603Mineral OilMineral Oil
    11822-3340Mineral OilMineral Oil
    11822-3601Mineral OilMineral Oil
    15127-334Mineral oilMineral oil
    15127-831Mineral OilMineral Oil
    0395-9135Mineral Oil HeavyMineral Oil
    0363-0006Mineral Oil Lubricant Laxativemineral oil
    0869-0831oilMineral Oil
    0363-8831Walgreens Lubricant Eye Drops Preservative FreeMineral Oil

    Trademark Results [Pure and Gentle]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PURE AND GENTLE
    PURE AND GENTLE
    81024082 1024082 Dead/Cancelled
    Davol, Inc.
    0000-00-00
    PURE AND GENTLE
    PURE AND GENTLE
    81016672 1016672 Dead/Cancelled
    Davol Inc.
    0000-00-00
    PURE AND GENTLE
    PURE AND GENTLE
    73791746 1767010 Dead/Cancelled
    BARUSCO AG
    1989-04-07
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.