FDA.reportPublic FDA data

Kroger Stool Softener

Product NDC
41226-714
11-digit product format
412260714
Labeler code
41226
Product ID
41226-714_3a31fda9-0dc3-4728-8530-a737f69b24fd
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium
Dosage form
LIQUID
Route
ORAL
Labeler
KROGER COMPANY
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-27
Substance
DOCUSATE SODIUM
Active strength
50 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Kroger Stool Softener
Brand name suffix
Fruit Punch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1248119Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b86f8f3d-594e-466c-854a-b8bff9f7a0b8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-714-08Kroger Stool SoftenerFruit Punch237 mL in 1 BOTTLE, PLASTICLIQUID2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-714KROGER STOOL SOFTENER FRUIT PUNCH (DOCUSATE SODIUM) LIQUID [KROGER COMPANY]3Current NDC, 1 package rows20240801_b86f8f3d-594e-466c-854a-b8bff9f7a0b8.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 32 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES5a503d8d-7899-4b1e-be6f-8e2a759af2652024-12-04WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESCVS Pharmacy, Inc.6dffc3f5-bae0-c436-e053-2991aa0a0f8b2024-12-02WarningsExact identifier
application number: M007
Pure and GentleMINERAL OILMedline Industries, LP96d4cad5-0602-4c31-94ed-3117b4fd4a942024-11-26WarningsExact identifier
application number: M007
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50 MGDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.af7533e6-8b06-48a4-940e-7ecb57b24b592024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a923e5ca-86fd-4bf9-9931-180ddfdeae662024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.7cf1df18-d658-4bff-8a62-365fc56569422024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mgDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.c5bdfbfc-d24a-4088-9b60-ecea8120ff432024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.85c64624-428d-46fa-8071-f42b8feec0492024-11-21WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd33251cb7-b7b1-4f6c-9e10-4fa64cbf03a02024-11-21WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
application number: M007
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
application number: M007
ReliefSODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATELeosons Overseas Corp5b301d5b-1e2c-47ed-a05f-d6be0fdfc9402024-11-19WarningsExact identifier
application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
application number: M007
Milk of Magnesia ConcentrateMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2a99a1a8-a830-429f-9cfd-3f29c3d3547c2024-11-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
application number: M007
Stratuscare Adult GlycerinGLYCERINStratus Pharmaceuticals3e1935da-5c1f-4942-98dd-320fade823212024-11-04WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSNb86f8f3d-594e-466c-854a-b8bff9f7a0b84
1248119docusate sodium 10 MG/ML Oral SuspensionSCDb86f8f3d-594e-466c-854a-b8bff9f7a0b84
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSYb86f8f3d-594e-466c-854a-b8bff9f7a0b84
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSYb86f8f3d-594e-466c-854a-b8bff9f7a0b84
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSYb86f8f3d-594e-466c-854a-b8bff9f7a0b84
1248119DOSS Sodium 10 MG/ML Oral SuspensionSYb86f8f3d-594e-466c-854a-b8bff9f7a0b84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41226-714-0841226071408237 mL in 1 BOTTLE, PLASTIC (41226-714-08) 237 ml2023-03-27NoNoCurrent