FDA.reportPublic FDA data

Pedia-Lax

Product NDC
0132-0113
11-digit product format
001320113
Labeler code
0132
Product ID
0132-0113_6c2dec84-5645-49f0-a3c2-882f4e28d67e
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
C.B. Fleet Company, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-28
Substance
DOCUSATE SODIUM
Active strength
50 mg/15mL
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
Pedia-Lax
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/15mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1088245Internal RxNorm lookup
1088249Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e908bea-ebab-44e7-919c-90002e6f5d42Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0113-24Pedia-Lax118 mL in 1 CARTONLIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0113PEDIA-LAX (DOCUSATE SODIUM) LIQUID [C.B. FLEET COMPANY, INC.]1Current NDC, 1 package rows20240929_0e908bea-ebab-44e7-919c-90002e6f5d42.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 33 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stratuscare Glycerin Laxative PediatricGLYCERINStratus Pharmaceuticals6ae6d3c4-bb3b-4436-b76d-8654bf871e662024-11-01WarningsExact identifier
application number: M007
Rite Aid Fiber TherapyMETHYLCELLULOSERITE AID CORPORATIONe50cea80-c020-4b85-b61f-d053f11f479b2024-10-30WarningsExact identifier
application number: M007
Rite Aid Fiber CapletsCALCIUM POLYCARBOPHILRITE AID CORPORATION06e46cb0-2928-479e-984d-2305fff995e02024-10-30WarningsExact identifier
application number: M007
Premier Value Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC2d580965-2bef-46ee-8532-fbe34330a4b42024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber TherapyMETHYLCELLULOSEPHARMACY VALUE ALLIANCE, LLCb875d5f8-02f3-4474-9fda-83091bc7de042024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber Therapy Original CoarsePSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC8c85a13d-ae99-4599-9a28-c3965caa63762024-10-28WarningsExact identifier
application number: M007
Premier ValueCALCIUM POLYCARBOPHILPHARMACY VALUE ALLIANCE, LLC4d766548-00d0-41bd-bb58-b69e037c77e22024-10-28WarningsExact identifier
application number: M007
Premier Value FiberPSYLLIUM HUSKChain Drug Consortium, LLCc507fe4a-1f8e-4780-a2f5-9da6e5922bef2024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber Therapy Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC85651bd7-e959-4455-a5ed-bd0223ce05632024-10-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c61c71-9a23-4bd3-e053-2a95a90ad4602024-10-26WarningsExact identifier
application number: M007
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.ae367381-7146-4307-823d-2bb44c1d42002024-10-25WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporationf7309f4a-f1f5-420e-bfc7-fb4495a5afba2024-10-24WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporation2540ae39-2218-0f6a-e063-6294a90a5efc2024-10-24WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMSam's West Incb0e99ebb-41fc-459f-86d2-f0e3527f97b02024-10-24WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMA-S Medication Solutionsef05ad45-7082-43e6-9533-a79c5aa0f3732024-10-22WarningsExact identifier
application number: M007
Bliss GVS ChildrenGLYCERINBliss GVS Pharma Limited03237ed2-265f-4acd-b504-d82b9263287c2024-10-17WarningsExact identifier
application number: M007
NATURAL Epsom SaltMAGNESIUM SULFATEUniversal Distribution Center LLCb2682e51-ffa4-4556-b2a6-b0dbd543fd4f2024-10-16WarningsExact identifier
application number: M007
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
application number: M007
BisacodylBISACODYLPadagis US LLC7eada0fc-5f83-43da-a56f-b0f5372982082024-10-10WarningsExact identifier
application number: M007
exchange select stool softenerDOCUSATE SODIUMArmy & Air Force Exchange Service14985848-d791-42b9-ad7e-810a85bb1ee12024-10-07WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1088245docustate sodium 50 MG in 15 mL Oral SolutionPSN0e908bea-ebab-44e7-919c-90002e6f5d421
1088249Pedia-Lax Stool Softener 50 MG in 15 mL Oral SolutionPSN0e908bea-ebab-44e7-919c-90002e6f5d421
1088249docusate sodium 3.33 MG/ML Oral Solution [Pedia-Lax Liquid]SBD0e908bea-ebab-44e7-919c-90002e6f5d421
1088245docusate sodium 3.33 MG/ML Oral SolutionSCD0e908bea-ebab-44e7-919c-90002e6f5d421
1088245docusate sodium 100 MG per 30 ML Oral SolutionSY0e908bea-ebab-44e7-919c-90002e6f5d421
1088245docusate sodium 50 MG per 15 ML Oral SolutionSY0e908bea-ebab-44e7-919c-90002e6f5d421
1088245DOSS Sodium 3.33 MG/ML Oral SolutionSY0e908bea-ebab-44e7-919c-90002e6f5d421
1088249DOSS Sodium 3.33 MG/ML Oral Solution [Pedia-Lax Liquid]SY0e908bea-ebab-44e7-919c-90002e6f5d421
1088249Pedia-Lax Liquid 3.33 MG/ML Oral SolutionSY0e908bea-ebab-44e7-919c-90002e6f5d421
1088249Pedia-Lax Stool Softener 50 MG per 15 ML Oral SolutionSY0e908bea-ebab-44e7-919c-90002e6f5d421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0132-0113-2400132011324118 mL in 1 CARTON (0132-0113-24) 118 ml2023-02-28NoNoCurrent