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 38 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative	DOCUSATE SODIUM	Care One (Retail Business Services, LLC.)	eb7f3d65-8741-407d-b3f3-1d9dda19684d	2024-03-05	Warnings	Exact identifier application number: M007
Fleet	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC	C.B. Fleet Company, Inc.	f50ba829-16c3-40a7-9822-8d6d00353b33	2024-02-29	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	4ce62421-97e0-4920-9a6d-9fa1f0f93fe4	2024-02-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	851a5dda-e72b-4067-a98f-54d3222f646e	2024-02-23	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	2ca80e23-f38a-4f77-b536-131cc9f0cf5b	2024-02-23	Warnings	Exact identifier application number: M007
Colon Detox	DOCUSATE SODIUM AND SENNOSIDES	OPMX LLC	0a4d3265-080c-d2ed-e063-6394a90adbee	2024-02-21	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	Best Choice (Valu Merchandisers Company)	4501d718-15a7-4e27-bdb1-8aa2d3ff06d0	2024-02-20	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Best Choice (Valu Merchandisers Company)	72bd251b-4e82-41ef-8362-39f95faf9916	2024-02-15	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON	CARDINAL HEALTH, INC. 063997360	10bdd5e6-3db2-8f9e-e063-6394a90a9b3f	2024-02-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	CARDINAL HEALTH, INC. 063997360	10beb3ec-a189-221d-e063-6394a90aabb5	2024-02-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	CARDINAL HEALTH, INC. 063997360	10bebb63-19b3-2e14-e063-6394a90a8d4e	2024-02-06	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Proficient Rx LP	f9ac0344-5864-4ac1-81bc-16878a5946c5	2024-02-01	Warnings	Exact identifier application number: M007
Purifi Hand Sanitizer	BENZALKONIUM CHLORIDE	Purifi LLC	9267069d-4cf5-4e48-a446-7dbebea16bf5	2024-01-31	Warnings	Exact identifier application number: M007
WOMENS LAXATIVE ENTERIC COATED	BISACODYL	CARDINAL HEALTH	ab34bc89-6738-d284-e053-2a95a90a5dc9	2024-01-11	Warnings	Exact identifier application number: M007
MAXIMUM STRENGTH LAXATIVE	SENNOSIDES	CARDINAL HEALTH	b7b13bfa-8a94-6f62-e053-2995a90abbf4	2024-01-10	Warnings	Exact identifier application number: M007
FIBER LAXATIVE	CALCIUM POLYCARBOPHIL	Magno-Humphries, Inc.	e4a921c5-1cf7-12ca-e053-2a95a90a6e04	2024-01-03	Warnings	Exact identifier application number: M007
Freskaro Castor Oil	CASTOR OIL	Pharma Nobis, LLC	fbd6bdd5-a7a1-3f28-e053-6294a90aab87	2023-12-28	Warnings	Exact identifier application number: M007
Humco Castor Oil	CASTOR OIL	Pharma Nobis, LLC	e42f9d37-1b07-177a-e053-2a95a90a9b06	2023-12-26	Warnings	Exact identifier application number: M007
Magnesium Citrate	FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Pharma Nobis, LLC	f0477328-eca1-9043-e053-2995a90aaa3d	2023-12-22	Warnings	Exact identifier application number: M007
Magnesium Citrate	FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	Pharma Nobis, LLC	f0489f6f-9e60-7d69-e053-2a95a90a9dfb	2023-12-22	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