FDA.reportPublic FDA data

Glycerin

Manufacturer
Rising Pharma Holdings, Inc. | Bliss GVS Pharma Limited
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:14:37

Label at a glance#

ProductGlycerin
Active ingredientGLYCERIN
Label structure12 sections

Storage and handling

Other information keep away from excessive heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)

Glycerin USP, 2 grams

OTC - PURPOSE SECTION

Purpose

Laxative

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For rectal use only

OTC - DO NOT USE SECTION

Do not use for longer than 1 week unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks

OTC - WHEN USING SECTION

When using this product it may cause rectal discomfort or a burning sensation

OTC - STOP USE SECTION

Stop use and ask a doctor if you have

  • rectal bleeding
  • no bowel movement after using this product

These may indicate a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 6 years of age and over : 1 suppository once daily
  • children under 6 years : do not use
  • insert 1 suppository well up into rectum and retain for 15 minutes
  • it need not melt to produce laxative action

STORAGE AND HANDLING SECTION

Other information

keep away from excessive heat.

INACTIVE INGREDIENT SECTION

Inactive ingredients

purified water, sodium stearate

OTC - QUESTIONS SECTION

Questions or Comments?

Call 1-844-474-7464

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Made in India

CODE NO.: MH/DRUGS/25-KD/724

Issued: 08/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57237-325-52 (5 blisters of 5 suppositories)

GLYCERIN SUPPOSITORIES 2 g

LAXATIVE

For fast, gentle relief of occasional constipation

Gly-supp-01Gly-supp-01

Gly-supp-02Gly-supp-02

NDC 57237-325-51 (5 suppositories in 1 blister pack)

Front Foil

Gly-supp-03Gly-supp-03

Back Foil

Gly-supp-04Gly-supp-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
104155glycerin 2 GM Rectal SuppositoryPSN4
104155glycerin 2000 MG Rectal SuppositorySCD4
104155glycerin 2 GM Rectal SuppositorySY4

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-325-16Glycerin6 in 1 BLISTER PACKSUPPOSITORY64
57237-325-21Glycerin2 in 1 CARTONSUPPOSITORY24
57237-325-51Glycerin5 in 1 BLISTER PACKSUPPOSITORY54
57237-325-52Glycerin5 in 1 CARTONSUPPOSITORY54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-325-21EA - Each57237-325727d12ed-4dc6-43e3-9474-eff01b170ab912024-02-14
57237-325-52EA - Each57237-325112f7281-cc90-4bbe-8a9e-06e7248d2dfe12024-02-14

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-32557237-325-16, 57237-325-21, 57237-325-51, 57237-325-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM STEARATEQU7E2XA9TGIACT
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
GlycerinGLYCERINRising Pharma Holdings, Inc.db539b39-9504-44d2-9bd5-ba6ffb4410242025-09-08WarningsExact identifier
ndc (package): 57237-325-16
ndc (package): 57237-325-52
ndc (package): 57237-325-51
ndc (package): 57237-325-21
ndc (product): 57237-325
ndc11 (package): 57237032516
ndc11 (package): 57237032552
ndc11 (package): 57237032551
ndc11 (package): 57237032521
spl id: 89913e09-2a56-491c-9a36-77ef2c1f28fe
spl set id: db539b39-9504-44d2-9bd5-ba6ffb441024

Reported adverse events (FAERS/openFDA)#

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