NDC 53329-014

Pure and Gentle Laxative

Sodium Phosphate

Pure and Gentle Laxative is a Rectal Enema in the Human Otc Drug category. It is labeled and distributed by Medline Industries, Inc.. The primary component is Sodium Phosphate, Dibasic; Sodium Phosphate, Monobasic.

Product ID53329-014_5d1be431-b6bf-1cf6-e053-2a91aa0a4f9b
NDC53329-014
Product TypeHuman Otc Drug
Proprietary NamePure and Gentle Laxative
Generic NameSodium Phosphate
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 NameSODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
Active Ingredient Strength7 g/118mL; g/118mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53329-014-11

1 BOTTLE in 1 BOX (53329-014-11) > 133 mL in 1 BOTTLE
Marketing Start Date2017-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53329-014-58 [53329001458]

Pure and Gentle Laxative ENEMA
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-11-03

NDC 53329-014-40 [53329001440]

Pure and Gentle Laxative ENEMA
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-04-09
Marketing End Date2015-06-10

NDC 53329-014-35 [53329001435]

Pure and Gentle Laxative ENEMA
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-04-09
Marketing End Date2015-06-10

NDC 53329-014-37 [53329001437]

Pure and Gentle Laxative ENEMA
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-04-09
Marketing End Date2015-06-10

NDC 53329-014-11 [53329001411]

Pure and Gentle Laxative ENEMA
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-11-10

Drug Details

Active Ingredients

IngredientStrength
SODIUM PHOSPHATE, DIBASIC7 g/118mL

OpenFDA Data

SPL SET ID:e3165538-75dd-4f0f-adc8-d4075de10f1e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283100

    • NDC Crossover Matching brand name "Pure and Gentle Laxative" or generic name "Sodium Phosphate"

    NDCBrand NameGeneric Name
    53329-014Pure and Gentle Laxativesodium phosphate
    53329-005Curad Saline Laxativesodium phosphate
    54973-3104FERRUM PHOSPHATEsodium phosphate
    54973-3431FERRUM PHOSPHATEsodium phosphate
    62106-1059NATRIUM PHOSPHORICUM 6XSodium Phosphate
    0536-7415Ready-to-UseSodium Phosphate
    11673-222Ready-to-Use EnemaSodium Phosphate
    0363-0005Saline Laxativesodium phosphate
    21130-005Saline Laxativesodium phosphate
    30142-005Saline Laxativesodium phosphate
    41163-005Saline Laxativesodium phosphate
    41520-005Saline Laxativesodium phosphate
    42507-111Saline Laxativesodium phosphate
    46122-500Saline Laxativesodium phosphate
    49348-005Saline Laxativesodium phosphate
    49738-005Saline Laxativesodium phosphate
    55319-005Saline Laxativesodium phosphate
    62011-0191Saline Laxativesodium phosphate
    62011-0500Saline Laxativesodium phosphate
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