FDA.reportPublic FDA data

Glycerin

Manufacturer
Chain Drug Marketing Association Inc. | DSC Laboratories Inc.
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:41:17

Label at a glance#

ProductGlycerin
Active ingredientGLYCERIN
Label structure8 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 2.1 g

Purpose

OTC - PURPOSE SECTION

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

Glycerin Suppositories, 50 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Glycerin Suppositories, 50 count

Distributed by Quality Choice

Novi, MI 48376-0995

www.qualitychoice.com

QC_50ct.jpg

Quality Choice 50ctQuality Choice 50ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
583084glycerin 2.1 GM Adult Rectal SuppositoryPSN1
583084glycerin 2100 MG Rectal SuppositorySCD1
583084glycerin 2.1 GM Rectal SuppositorySY1
583084glycerin 82.5 % Adult Rectal SuppositorySY1

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-130635515982406GTIN-13: 0635515982406
EAN-13: 0635515982406
GTIN-12: 635515982406
UPC-A: 635515982406
GTIN storage (14 digits): 00635515982406		QC_50ct.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-284-25Glycerin25 in 1 JARSUPPOSITORY251
83324-284-50Glycerin50 in 1 JARSUPPOSITORY501

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
83324-28483324-284-50, 83324-284-25

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
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXACTIB

Source Document#

Source XML

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 Marketing Association Inc.424d91f0-ecf9-6d9b-e063-6394a90a80062025-10-29WarningsExact identifier
ndc (package): 83324-284-50
ndc (package): 83324-284-25
ndc (product): 83324-284
ndc11 (package): 83324028425
ndc11 (package): 83324028450
spl id: 424d91bf-a81e-a627-e063-6294a90a3c3b
spl set id: 424d91f0-ecf9-6d9b-e063-6394a90a8006

Reported adverse events (FAERS/openFDA)#

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