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 34 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP8678a3ee-0e2c-4c95-ad2e-83aa601f32382024-10-01WarningsExact identifier
application number: M007
Pedia-LaxDOCUSATE SODIUMC.B. Fleet Company, Inc.0e908bea-ebab-44e7-919c-90002e6f5d422024-10-01WarningsExact identifier
application number: M007
ndc (product): 0132-0113
Natural Vegetable Laxative and Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c562e1-4080-44cb-e053-2a95a90a42222024-09-25WarningsExact identifier
application number: M007
SENNA-S LAXATIVE WITH STOOL SOFTENERSENNOSIDESBasic Drugs, Inc.d32b9956-fc04-8d64-e053-2a95a90a17b32024-09-14WarningsExact identifier
application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCe8be12c5-c591-eadd-e053-2a95a90a431b2024-09-13WarningsExact identifier
application number: M007
SennaSENNOSIDESProficient Rx LP5f7f0df4-dabe-4c8f-a2b5-766f20af2f462024-09-01WarningsExact identifier
application number: M007
Fiber caplets 147CALCIUM POLYCARBOPHILChain Drug Marketing Association Inc.17e2a50d-1867-49fe-e063-6394a90a56df2024-08-27WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVE PILLSSENNOSIDESTARGET CORPORATION7cae52ae-931c-3e7c-e053-2991aa0a83962024-08-22WarningsExact identifier
application number: M007
STOOL SOFTENER AND STIMULANT LAXATIVEDOCUSATE SODIUM AND SENNOSIDESTARGET CORPORATION7cac99da-8d89-0aee-e053-2991aa0a0fd92024-08-22WarningsExact identifier
application number: M007
SENNA LAXATIVESENNOSIDES 8.6 MGTARGET CORPORATION7cab058f-3647-7124-e053-2a91aa0a41bd2024-08-22WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPadagis Israel Pharmaceuticals Ltdbce3b245-ec47-4e62-9cad-bb12d0812c182024-08-15WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.56f7966a-c95e-3ce3-e054-00144ff88e882024-08-14WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMProficient Rx LPccfa095c-77f0-41ff-84f8-e02d983c7c742024-08-01WarningsExact identifier
application number: M007
Magnesium CitrateHARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMONHarris Teeter, LLC1e8e01fc-2c89-9722-e063-6394a90a6acf2024-07-31WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESBest Choice (Valu Merchandisers Company)d5f90aa1-78e5-491f-b09d-399d54f3def12024-07-31WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESWalgreensdb528659-768a-46e0-a340-9fbcdb25ea5e2024-07-25WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESWalgreensbfa089a6-4767-45e0-b663-ee7e8949d9a42024-07-25WarningsExact identifier
application number: M007
Dr. FibraPSYLLIUM HUSKPharmadel LLC1a6151c9-e1c4-f0c1-e063-6394a90aad242024-07-22WarningsExact identifier
application number: M007
BISACODYLBISCODYLTARGET CORPORATION8ed281d5-b17e-e3bb-e053-2995a90a25902024-07-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE CALCIUMWalgreensb6f0770e-671d-4965-9275-b1c224d7f06a2024-07-10WarningsExact 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