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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6ae6d3c4-bb3b-4436-b76d-8654bf871e66	Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58980-409-12	EA - Each	58980-409	97bca87c-57f7-4dfb-8f0d-d667ef8bf62c	1	2015-08-04
58980-409-25	EA - Each	58980-409	785a1b6b-78ad-42ec-b6f0-b130d0fcef56	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Glycerin	ACTIVE INGREDIENT	PDC6A3C0OX	STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS]	1
Glycerin	ACTIVE MOIETY	PDC6A3C0OX	STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS]	1
SODIUM STEARATE	INACTIVE INGREDIENT	QU7E2XA9TG	STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS]	1

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 28 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Laxative Docusate Sodium with Senna	DOCUSATE SODIUM AND SENNOSIDES	TOPCO ASSOCIATES LLC	cf9075d8-e20e-419a-b996-9b12f49f05f2	2025-01-01	Warnings	Exact identifier application number: M007
Vegetable Laxative and Stool Softner	DOCUSATE SODIUM AND SENNOSIDES	TOPCO ASSOCIATES LLC	e84d693d-0041-4c11-8f6a-b5c332f79af9	2025-01-01	Warnings	Exact identifier application number: M007
Acetaminophen	EXTRA STRENGTH PAIN RELIEF	NuCare Pharmaceuticals,Inc.	a32f346e-71d0-cc11-e053-2a95a90ae88c	2024-12-31	Warnings	Exact identifier application number: M007
Laxacin	DOCUSATE SODIUM AND SENNOSIDES	Advanced Rx Pharmacy of Tennessee, LLC	fe7d4d75-0f8a-1e7d-e053-6394a90afb4d	2024-12-31	Warnings	Exact identifier application number: M007
NATUREPLEX Enema	(SALINE)	Natureplex, LLC	0bd6d0a8-33e5-40be-a6c6-33fea92b11dd	2024-12-31	Warnings	Exact identifier application number: M007
Magnesium Citrate	CVS MAGNESIUM CITRATE ORAL SOLUTION - LEMON	CVS Pharmacy, Inc.	fb7f9b67-ff0e-3af4-e053-6294a90ac539	2024-12-30	Warnings	Exact identifier application number: M007
Magnesium Citrate	CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	CVS Pharmacy, Inc.	fb808dc5-bf80-836c-e053-6294a90a80aa	2024-12-30	Warnings	Exact identifier application number: M007
Magnesium Citrate	CVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	CVS Pharmacy, Inc.	fb80ffce-a7b6-7f19-e053-6294a90a5c6b	2024-12-30	Warnings	Exact identifier application number: M007
Foster and Thrive Castor Oil	CASTOR OIL	Strategic Sourcing Services, LLC	004d1dc2-47c1-84d1-e063-6394a90a2471	2024-12-30	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	A-S Medication Solutions	946abcdb-96bd-43e6-992a-bb97679c00f0	2024-12-30	Warnings	Exact identifier application number: M007
HEB Maximum strength Laxative pills	SENNOSIDES	H E B	86e5dff5-91e6-47a5-8f3c-b1e86adfc1f4	2024-12-26	Warnings	Exact identifier application number: M007
Equaline Regular Strength Chocolated Stimulant Laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	e9200d63-a0d1-4f68-bb5e-7507c46cf800	2024-12-26	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	WALGREEN COMPANY	effad954-b70d-d8e6-e053-2a95a90acaf7	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	WALGREEN COMPANY	effad365-d76e-71af-e053-2995a90aa020	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	WALGREEN COMPANY	effaeff6-c48b-1558-e053-2995a90ab52f	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	STRATEGIC SOURCING SERVICES	f9e1291a-f64d-2431-e053-6394a90a35f1	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	AMERISOURCE BERGEN	f384094e-c4d2-3882-e053-2995a90a7794	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	AMERISOURCE BERGEN	f3847b0f-802d-73d7-e053-2a95a90a5bbe	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	STRATEGIC SOURCING SERVICES	f9e1291a-f650-2431-e053-6394a90a35f1	2024-12-23	Warnings	Exact identifier application number: M007
Leader Regular Strength Chocolate Laxative sennosides	SENNOSIDES	CARDINAL HEALTH	1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e	2024-12-23	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
252062	glycerin 1 GM pediatric Rectal Suppository	PSN	6ae6d3c4-bb3b-4436-b76d-8654bf871e66	4
252062	glycerin 1000 MG Rectal Suppository	SCD	6ae6d3c4-bb3b-4436-b76d-8654bf871e66	4
252062	glycerin 1 GM pediatric Rectal Suppository	SY	6ae6d3c4-bb3b-4436-b76d-8654bf871e66	4

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Stratuscare Glycerin Suppositories Laxative Pediatric	Stratus Pharmaceuticals \| Tarmac Products	2024-11-01	HUMAN OTC DRUG LABEL	4