FDA.reportPublic FDA data

Glycerin Laxative

Manufacturer
NeilMed Pharmaceuticals Inc.
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:56

Label at a glance#

ProductGlycerin Laxative
Active ingredientGLYCERIN
Label structure14 sections

Indications and uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in ¼ to 1 hour

Dosage and administration

adults and children 6 years of age and over : insert 1 suppository well into the rectum and retain for 15 minutes; it need not melt to produce laxative action. Do not exceed 1 suppository daily or as directed by a doctor. children 2 to under 6 years: use Child Suppositories children under 2 years: ask a doctor

Storage and handling

• keep tightly closed • avoid excessive heat

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)
Glycerin, USP 2 grams

Purpose

OTC - PURPOSE SECTION

Active ingredient (in each suppository) ...............Purpose
Glycerin, USP 2 grams ...................................... Laxative

Uses

INDICATIONS & USAGE SECTION

• relieves occasional constipation (irregularity)
• generally produces bowel movement in ¼ to 1 hour

Warnings

WARNINGS SECTION

For rectal use only

Do not use

OTC - DO NOT USE SECTION

laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks

When using this product

OTC - WHEN USING SECTION

you may have rectal discomfort or a burning sensation

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after use of a laxative.
These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

adults and children 6 years of age and over : insert 1 suppository well into the rectum and retain for 15 minutes; it need not melt to produce laxative action. Do not exceed 1 suppository daily or as directed by a doctor.

children 2 to under 6 years: use Child Suppositories

children under 2 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• keep tightly closed • avoid excessive heat

Inactive ingredients:

INACTIVE INGREDIENT SECTION

purified water, sodium hydroxide, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Glycerin SuppositoryGlycerin Suppository

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
104155glycerin 2 GM Rectal SuppositoryPSN2
104155glycerin 2000 MG Rectal SuppositorySCD2
104155glycerin 2 GM Rectal SuppositorySY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-322-01Glycerin Laxative25 in 1 JARSUPPOSITORY252
13709-322-01Glycerin Laxative1 in 1 CAPSULESUPPOSITORY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-322GLYCERIN LAXATIVE (GLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEF) SUPPOSITORY [NEILMED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20250119_03b4be69-6488-76be-e063-6394a90a7edf.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-32213709-322-01

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
STEARIC ACID4ELV7Z65APIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
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
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
ndc (package): 13709-322-01
ndc (product): 13709-322
ndc11 (package): 13709032201
spl id: 2beb2049-b67f-b7a5-e063-6394a90a3a15
spl set id: 03b4be69-6488-76be-e063-6394a90a7edf

Reported adverse events (FAERS/openFDA)#

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