FDA.reportPublic FDA data

Stratuscare Glycerin Laxative Pediatric

Product NDC
58980-409
11-digit product format
589800409
Labeler code
58980
Product ID
58980-409_4c627848-1463-4afc-bfd6-e310b1ef0ffa
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Stratus Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-01
Substance
GLYCERIN
Active strength
1 g/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Stratuscare Glycerin Laxative Pediatric
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
252062Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ae6d3c4-bb3b-4436-b76d-8654bf871e66Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-409-12Stratuscare Glycerin Laxative Pediatric12 in 1 JARSUPPOSITORY124
58980-409-25Stratuscare Glycerin Laxative Pediatric25 in 1 JARSUPPOSITORY254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-409-12EA - Each58980-40997bca87c-57f7-4dfb-8f0d-d667ef8bf62c12015-08-04
58980-409-25EA - Each58980-409785a1b6b-78ad-42ec-b6f0-b130d0fcef5612015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GlycerinACTIVE INGREDIENTPDC6A3C0OXSTRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS]1
GlycerinACTIVE MOIETYPDC6A3C0OXSTRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS]1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGSTRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS]1
WaterINACTIVE INGREDIENT059QF0KO0RSTRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-409STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20241103_6ae6d3c4-bb3b-4436-b76d-8654bf871e66.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
ndc (product): 58980-409
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
252062glycerin 1 GM pediatric Rectal SuppositoryPSN6ae6d3c4-bb3b-4436-b76d-8654bf871e664
252062glycerin 1000 MG Rectal SuppositorySCD6ae6d3c4-bb3b-4436-b76d-8654bf871e664
252062glycerin 1 GM pediatric Rectal SuppositorySY6ae6d3c4-bb3b-4436-b76d-8654bf871e664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58980-409-125898004091212 SUPPOSITORY in 1 JAR (58980-409-12) 12 suppository2014-06-010000-00-00NoNoCurrent
58980-409-255898004092525 SUPPOSITORY in 1 JAR (58980-409-25) 25 suppository2014-06-010000-00-00NoNoCurrent