Home NDC 58980-409 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 Ingredient Strength GLYCERIN 1 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 252062 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58980-409-12 Stratuscare Glycerin Laxative Pediatric 12 in 1 JAR SUPPOSITORY 12 4 58980-409-25 Stratuscare Glycerin Laxative Pediatric 25 in 1 JAR SUPPOSITORY 25 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58980-409 STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 2 package rows 20241103_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 14 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58980-409-12 58980040912 12 SUPPOSITORY in 1 JAR (58980-409-12) 12 suppository 2014-06-01 0000-00-00 No No Current 58980-409-25 58980040925 25 SUPPOSITORY in 1 JAR (58980-409-25) 25 suppository 2014-06-01 0000-00-00 No No Current