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

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 Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX
Rxcui252062

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 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

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