MedPath

Glycerin

Glycerin Suppositories 2 g

Approved
Approval ID

db539b39-9504-44d2-9bd5-ba6ffb441024

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 8, 2025

Manufacturers
FDA

Rising Pharma Holdings, Inc.

DUNS: 116880195

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Glycerin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57237-325
Application NumberM007.54
Product Classification
M
Marketing Category
C200263
G
Generic Name
Glycerin
Product Specifications
Route of AdministrationRECTAL
Effective DateSeptember 8, 2025
FDA Product Classification

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM STEARATEInactive
Code: QU7E2XA9TG
Classification: IACT
GLYCERINActive
Quantity: 2 g in 1 1
Code: PDC6A3C0OX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/8/2025

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

GLYCERIN SUPPOSITORIES 2 g

LAXATIVE

For fast, gentle relief of occasional constipation

Gly-supp-01

Gly-supp-02

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

Front Foil

Gly-supp-03

Back Foil

Gly-supp-04

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/8/2025

**Uses**

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/8/2025

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

Made in India

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

Issued: 08/2023

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/8/2025

Active ingredient (in each suppository)

Glycerin USP, 2 grams

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/8/2025

Purpose

Laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 9/8/2025

Warnings

**For rectal use only**

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

Ask a doctor before use if you have

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

When using this productit may cause rectal discomfort or a burning sensation

Stop use and ask a doctor if you have

  • rectal bleeding
  • no bowel movement after using this product

These may indicate a serious condition.

**Keep out of reach of children.**

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/8/2025

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

LOINC: 44425-7Updated: 9/8/2025

Other information

keep away from excessive heat.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/8/2025

Inactive ingredients

purified water, sodium stearate

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/8/2025

Questions or Comments?

Call1-844-474-7464

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Glycerin - FDA Drug Approval Details