Glycerin

Product NDC: 52316-725
11-digit product format: 523160725
Labeler code: 52316
Product ID: 52316-725_41e9f956-2af0-7c10-e063-6394a90a4a23
Type: HUMAN OTC DRUG
Nonproprietary name: Glycerin
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: DSC Laboratories Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-04-17
Substance: GLYCERIN
Active strength: 2.1 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52316-725	52316-725-25	D	Discontinued by firm		2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Glycerin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYCERIN	2.1 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
583084	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
a381838b-d1ae-11c5-e053-2a95a90a7bcb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52316-725-25	Glycerin	25 in 1 JAR	SUPPOSITORY	25		8
52316-725-50	Glycerin	50 in 1 JAR	SUPPOSITORY	50		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52316-725	GLYCERIN SUPPOSITORY [DSC LABORATORIES INC.]	7	Current NDC, Legacy NDC, 2 package rows	20241215_a381838b-d1ae-11c5-e053-2a95a90a7bcb.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 31 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEB Stool Softener	DOCUSATE SODIUM	H E B	afc54b8e-03d9-418c-9322-97d68f929031	2024-12-18	Warnings	Exact identifier application number: M007
Foster and Thrive Gentle Laxative	BISACODYL	Strategic Sourcing Services LLC	d03c2c42-d9d9-4b4b-a6ae-31d99425a228	2024-12-18	Warnings	Exact identifier application number: M007
EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE	SENNOSIDES	Haleon US Holdings LLC	59a26a7f-516f-4507-8dec-f40cf6cfaffc	2024-12-17	Warnings	Exact identifier application number: M007
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE	SENNOSIDES	Haleon US Holdings LLC	fb170340-c996-46cf-b165-84e136ba4151	2024-12-17	Warnings	Exact identifier application number: M007
Senna Syrup	NATURAL VEGETABLE LAXATIVE	Bryant Ranch Prepack	7d1f092e-0e5b-4fed-a095-64449751582d	2024-12-16	Warnings	Exact identifier application number: M007
Drug Mart Vegetable Laxative plus Stool Softener	DOCUSATE SODIUM, SENNOSIDES	Discount Drug Mart, Inc	1b6d59e8-112f-447f-b6e9-526b7d3bd01e	2024-12-13	Warnings	Exact identifier application number: M007
Drug Mart Stool Softener plus Stimulant Laxative	DOCUSATE SODIUM, SENNOSIDES	Discount Drug Mart, Inc	caf74258-922c-4b69-9bd6-57b3e918c7a6	2024-12-13	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	National Vitamin Company	0c66642c-82cb-42cd-82bb-5f95852cc5d1	2024-12-12	Warnings	Exact identifier application number: M007
Foster and Thrive Fiber Laxative 147	CALCIUM POLYCARBOPHIL	Strategic Sourcing Services LLC	88d341a6-28aa-4a20-bfed-1d5f3106c2ae	2024-12-12	Warnings	Exact identifier application number: M007
Pedia-Lax	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC	C.B. Fleet Company, Inc.	f001a37d-8ed4-428b-af12-d6a83c22c127	2024-12-12	Warnings	Exact identifier application number: M007
Careone Milk of magnesia Original Milk of Magnesia Original	MAGNESIUM HYDROXIDE	Retail Business Services, LLC.	13ffb00b-7c6f-47aa-bc82-2402d121a758	2024-12-11	Warnings	Exact identifier application number: M007
CareOne Milk of Magnesia Cherry	MAGNESIUM HYDROXIDE	Retail Business Services, LLC.	1822f90d-f693-48d7-b338-a3f2ddfac4df	2024-12-11	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	GOOD SENSE	a951b6d0-9182-e1bc-e053-2a95a90a12b1	2024-12-09	Warnings	Exact identifier application number: M007
milk of magnesia	MAGNESIUM HYDROXIDE	CVS Pharmacy	b3a36251-edd6-4201-8da1-85d7a6ede173	2024-12-05	Warnings	Exact identifier application number: M007
CITRUCEL	METHYLCELLULOSE	Haleon US Holdings LLC	d27f6742-2dcc-451e-b803-6ffe183038ec	2024-12-05	Warnings	Exact identifier application number: M007
Laxacin	DOCUSATE SODIUM AND SENNOSIDES	Alexso, Inc	0df9abaf-3997-4dde-8003-ae3d8d07cf39	2024-12-04	Warnings	Exact identifier application number: M007
NuValu Epsom Salt	MAGNESIUM SULFATE (HEPTAHYDRATE)	J C SALES	9f3cf9a4-e5c0-41ff-9fd3-63efb0d973cd	2024-12-04	Warnings	Exact identifier application number: M007
NuValu Epsom Salt	MAGNESIUM SULFATE (HEPTAHYDRATE)	J C SALES	5a503d8d-7899-4b1e-be6f-8e2a759af265	2024-12-04	Warnings	Exact identifier application number: M007
SENNOSIDES	SENNOSIDES	CVS Pharmacy, Inc.	6dffc3f5-bae0-c436-e053-2991aa0a0f8b	2024-12-02	Warnings	Exact identifier application number: M007
Pure and Gentle	MINERAL OIL	Medline Industries, LP	96d4cad5-0602-4c31-94ed-3117b4fd4a94	2024-11-26	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
583084	glycerin 2.1 GM Adult Rectal Suppository	PSN	a381838b-d1ae-11c5-e053-2a95a90a7bcb	8
583084	glycerin 2100 MG Rectal Suppository	SCD	a381838b-d1ae-11c5-e053-2a95a90a7bcb	8
583084	glycerin 2.1 GM Rectal Suppository	SY	a381838b-d1ae-11c5-e053-2a95a90a7bcb	8
583084	glycerin 82.5 % Adult Rectal Suppository	SY	a381838b-d1ae-11c5-e053-2a95a90a7bcb	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52316-725-25	52316072525	25 in 1 JAR						Historical
52316-725-50	52316072550	50 SUPPOSITORY in 1 JAR (52316-725-50)	50 suppository	2020-04-17	0000-00-00	No	No	Current