NDC 17856-0398

Stool Softener Liquid

Docusate Sodium

Stool Softener Liquid is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Atlantic Biologicals Corp.. The primary component is Docusate Sodium.

Product ID17856-0398_42953e6a-873c-4c32-afa7-94196611cc1c
NDC17856-0398
Product TypeHuman Otc Drug
Proprietary NameStool Softener Liquid
Generic NameDocusate Sodium
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2017-09-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameATLANTIC BIOLOGICALS CORP.
Substance NameDOCUSATE SODIUM
Active Ingredient Strength50 mg/5mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 17856-0398-1

50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0398-1) > 25 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2021-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0398-1 [17856039801]

Stool Softener Liquid LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-06

NDC 17856-0398-2 [17856039802]

Stool Softener Liquid LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-06

Drug Details

Active Ingredients

IngredientStrength
DOCUSATE SODIUM50 mg/5mL

OpenFDA Data

SPL SET ID:3bcab14d-a4b2-433a-9d1f-5dec61c7ae24
Manufacturer
UNII

NDC Crossover Matching brand name "Stool Softener Liquid" or generic name "Docusate Sodium"

NDCBrand NameGeneric Name
46122-399Stool Softener LiquidStool Softener Liquid
17856-0398Stool Softener LiquidStool Softener Liquid
0113-7004basic care stool softenerDocusate sodium
0121-0544Docusate SodiumDocusate Sodium
0363-0655Gentle Stool SoftenerDocusate sodium
0113-0486good sense stool softenerDocusate sodium
0363-6550LaxativeDocusate Sodium
0132-0106Pedia-LaxDocusate Sodium
0280-1012Phillips Stool Softenerdocusate sodium
0363-0238Stool SoftenerDOCUSATE SODIUM
0363-0239Stool SoftenerDOCUSATE SODIUM
0363-5790Stool SoftenerDocusate Sodium
0363-8540Stool SoftenerDocusate Sodium
0363-0016Stool Softener LaxativeDOCUSATE SODIUM
0363-0679Stool Softener LaxativeDOCUSATE SODIUM
0363-4100Stool Softener LaxativeDocusate Sodium
0363-4202Stool Softener LaxativeDocusate Sodium
0363-8530Stool Softener LaxativeDocusate Sodium
0363-7140Walgreens Stool SoftenerDocusate sodium

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