FDA.reportPublic FDA data

Glycerin

Manufacturer
Chain Drug Consortium LLC | DSC Laboratories, Inc.
Effective date
2025-10-16
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:40:08

Label at a glance#

ProductGlycerin
Active ingredientGLYCERIN
Label structure9 sections

Indications and uses

for relief of occasional constipation this product generally produces a bowel movement in 1/4 to 1 hour

Dosage and administration

Single daily dosage adults and children 6 years and over 1 suppository, or as directed by a doctor children 2 to under 6 years use Child Suppositories Insert suppository well up into rectum. Suppository need not melt completely to produce laxative action.

Label contents#

Full prescribing information#

Active ingredient (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Glycerin 2 g

Purpose

OTC - PURPOSE SECTION

Hyperosmotic laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation
  • this product generally produces a bowel movement in 1/4 to 1 hour

Warnings

WARNINGS SECTION

For rectal use only

May cause rectal discomfort of burning sensation

Ask a Doctor before using any laxative if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Stop use and consult a doctor if you have

OTC - STOP USE SECTION

  • rectal bleeding
  • no bowel movement after using this product

These symptoms may indicate a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Single daily dosage

adults and children 6 years and over 1 suppository, or as directed by a doctor

children 2 to under 6 years use Child Suppositories

Insert suppository well up into rectum.

Suppository need not melt completely to produce laxative action.

Other information

OTHER SAFETY INFORMATION

  • Store container tightly closed.
  • Keep away from excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, sodium hydroxide, stearic acid

Qestions or comments?

OTC - QUESTIONS SECTION

1-800-492-5988

Glycerin Suppositories, 50 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PremVal720.jpg

The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

Glycerin Suppositories, 50 count

Distributed by

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue

Wayne, PA 19087

Premier Value AdultPremier Value Adult

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
104155glycerin 2 GM Rectal SuppositoryPSN12
104155glycerin 2000 MG Rectal SuppositorySCD12
104155glycerin 2 GM Rectal SuppositorySY12

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130840986015809GTIN-13: 0840986015809
EAN-13: 0840986015809
GTIN-12: 840986015809
UPC-A: 840986015809
GTIN storage (14 digits): 00840986015809		PremVal720.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-015-79Glycerin25 in 1 JARSUPPOSITORY2512
68016-015-80Glycerin50 in 1 JARSUPPOSITORY5012
68016-015-81Glycerin100 in 1 JARSUPPOSITORY10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-015-79EA - Each68016-01532781bb2-c0bf-470c-ba1d-88bb3972e10512022-06-06
68016-015-80EA - Each68016-015d3bf11b7-d20b-4134-88eb-0c8c43d879cc12022-06-06
68016-015-81EA - Each68016-0153a444d56-2c92-440b-a5c4-9c951ec5900812022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-01568016-015-81, 68016-015-80, 68016-015-79

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112024-12-12full-release2026-06-01 00:43:10

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
ndc (package): 68016-015-80
ndc (package): 68016-015-81
ndc (package): 68016-015-79
ndc (product): 68016-015
ndc11 (package): 68016001581
ndc11 (package): 68016001579
ndc11 (package): 68016001580
spl id: 4147d0b9-1055-875a-e063-6294a90a63bb
spl set id: 4694f05b-d927-4e15-9630-a0a1cddb3cbb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.