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 10 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Oil	MINERAL OIL	Better Living Brands, LLC	7f2f1b30-497a-4c53-accc-8455169b17b3	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Family Dollar Stores, Inc	cc97cfb5-cd40-4589-942a-5bee611a2812	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Family Dollar Stores, Inc	0ac1896d-7ed9-44e5-bf07-147826237273	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Chain Drug Marketing Association	4a003bb1-425d-cd97-e063-6294a90a5dda	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Better Living Brands, LLC	d8176ef6-cc68-4185-b5eb-e887562f6aaa	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Better Living Brands, LLC	07732845-c9ce-47bb-8b63-36a3d5ddf8b7	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M007
stimulant laxative	BISACODYL	BIONPHARMA INC.	4b1f7db3-c6a8-7f6a-e063-6394a90a5829	2026-02-22	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Nice-Pak Products, LLC	ff6c8022-9522-4eae-b8ff-994ee37fba06	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Perrigo Direct, Inc	09e32476-1c60-4f1e-a51c-5fab2e744b30	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Perrigo Direct, Inc	22991685-8228-41e1-a13e-f57961e8dd0e	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Perrigo Direct, Inc	24478279-9a11-4e12-956d-57dc7debf941	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Perrigo Direct, Inc	f1656280-fad9-4922-9d5c-be774a8b1422	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Meijer, Inc.	3b8eae67-9e27-46bd-ab2b-02c719786bab	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Meijer, Inc.	c4d03837-193b-4817-8b78-fbdfb9122f19	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Meijer, Inc.	2070a4a6-7968-49f2-84ec-53bd1cd82445	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Meijer, Inc.	652d1da9-a71f-4113-9ef3-da0916724625	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
SENNA-S	DOCUSATE SODIUM AND SENNOSIDES	Advanced Rx LLC	d148be81-79b4-41f7-b8d8-a0e85b661592	2026-02-18	Warnings	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Target Corporation	a8e52a22-7c30-40c0-8f78-523775743bfb	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Target Corporation	526508f0-e908-4e3d-88f5-404a95f6de76	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M007
CVS Pharmacy	SALINE LAXATIVE	CVS Pharmacy	edd58c52-18de-4ec4-aec3-44f3e17607a7	2026-02-17	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