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Glycerin

Generic Name
Glycerin
Brand Names
Clear Eyes Cooling Comfort, Clear Eyes Redness Relief Reformulated Nov 2011, Fleet Mineral Oil, Genteal Tears, Glycerolyte 57, Pedia-lax Liquid, Preparation H Cream, Procalamine 3, Refresh Optive Advanced, Refresh Optive Extended Therapy, Synovisol, Tears Lubricant
Drug Type
Small Molecule
Chemical Formula
C3H8O3
CAS Number
56-81-5
Unique Ingredient Identifier
PDC6A3C0OX

Overview

A trihydroxy sugar alcohol that is an intermediate in carbohydrate and lipid metabolism.

Indication

It is used as a solvent, emollient, pharmaceutical agent, and sweetening agent.

Associated Conditions

  • Cold Sore
  • Constipation
  • Dry Mouth
  • Dry Skin
  • Dry throat
  • Edema of the cerebrum
  • Increase in Intracranial Pressure (ICP)
  • Occasional Constipation
  • Ocular Discomfort
  • Ocular Hypertension
  • Ocular Irritation
  • Skin Infections
  • Sore Throat
  • Mouth soreness
  • Sensation of burning in the eyes

Research Report

Published: Aug 19, 2025

A Comprehensive Monograph on Glycerin (Glycerol): Pharmacology, Clinical Applications, and Safety Profile

1.0 Introduction and Chemical Identity

1.1 Overview of Glycerin as a Polyol Compound

Glycerin, also known as glycerol, is a simple polyol compound that holds a position of fundamental importance in both biological systems and industrial processes. Structurally, it is a trihydroxy sugar alcohol, or triol, and serves as a critical intermediate in the metabolism of carbohydrates and lipids.[1] It is a naturally occurring substance, forming the structural backbone of all lipids known as glycerides.[2] In its pure form, glycerin is a clear, colorless, odorless, and viscous liquid characterized by a distinctly sweet taste.[2] These unique physicochemical properties, particularly its strong affinity for water, have led to its ubiquitous use across a vast spectrum of applications. It is a cornerstone ingredient in pharmaceutical formulations, a staple in the cosmetics and personal care industries, a versatile additive in food manufacturing, and a valuable component in numerous industrial applications.[3] Its versatility is such that it can function as an active pharmaceutical ingredient, a pharmaceutical excipient, a food additive, and an industrial chemical, making a comprehensive understanding of its properties and actions essential for a wide range of scientific and clinical disciplines.

1.2 Nomenclature and Identification

Continue reading the full research report

Clinical Trials

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FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
United Natural Foods, Inc
83455-213
OPHTHALMIC
0.25 g in 100 mL
1/1/2024
HYDRASPHERE PLUS LLC
85579-005
CUTANEOUS
1 g in 40 mL
4/28/2025
GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
84558-008
CUTANEOUS
4 g in 100 g
5/7/2025
STEEL CITY HEALTH PRIVATE LIMITED
85884-025
ORAL
100 mg in 1 mL
7/21/2025
CorneaCare Inc
82875-003
OPHTHALMIC
0.63 g in 100 mL
8/2/2025
Allergan, Inc.
0023-4515
OPHTHALMIC
10 mg in 1 mL
8/22/2025
Rising Pharma Holdings, Inc.
57237-339
RECTAL
2 g in 1 1
7/16/2025
Rising Pharma Holdings, Inc.
57237-338
RECTAL
1.2 g in 1 1
6/12/2025
Neilmed Pharmaceuticals Inc.
13709-335
TOPICAL
144 mg in 1 g
6/11/2025
The Kroger Co.
30142-573
OPHTHALMIC
0.25 g in 100 mL
1/1/2024

EMA Drug Approvals

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Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Company
Licence No.
Strength
Registration Date
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TGA Drug Approvals

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Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Hyaluronic acid gel
381373
Honest International Pty Ltd
Medicine
A
12/24/2021
Aelo
490647
Maebo Pty Ltd
Medicine
A
6/3/2025
COLOXYL GLYCEROL SUPPOSITORIES FOR ADULTS glycerol 2.8 g strip pack
421421
Medicine
A
9/7/2023
Joint Rebuild
294437
Medicine
A
9/28/2017
QV Flare Up Cream
252972
Medicine
A
8/6/2015
Cooling Gel
381374
Honest International Pty Ltd
Medicine
A
12/24/2021
Curezma Junior ECZEMA Soothing Sensitive Lotion
449059
Medicine
A
5/20/2024
ORAL-EZE GEL benzocaine 30mg/g cetylpyridinium chloride 100 micrograms /g, glycerol 100mg/g, ethanol 374 mg/g gel tube
39774
Medicine
A
4/27/1992
PETRUS GLYCEROL 2.8g SUPPOSITORIES FOR ADULTS strip pack
12789
Medicine
A
8/28/1991
SM33 GEL tube
12182
Pharmaco Australia Ltd
Medicine
A
8/9/1991

Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
TEARS NATURALE FORTE
Alcon Canada Inc
02246397
Solution - Ophthalmic
0.2 %
1/2/2003
AGAROL PLAIN EML
warner-lambert canada inc.
01945971
Emulsion - Oral
800 MG / 5 ML
12/31/1992
VISINE FOR DRY EYE EYE REVIVAL
johnson & johnson inc
02436132
Drops - Ophthalmic
0.2 % / V/V
5/19/2016
LUBRICANT EYE DROPS/ ARTIFICIAL TEARS
bausch & lomb inc
02321696
Drops - Ophthalmic
0.3 % / W/V
8/25/2009
GLYCERIN USP (LIQUID)
kolmar canada inc.
00892076
Liquid - Topical
100 %
12/31/1995
GLYCERINE LIQ 100%
produits marc-o (1987) inc., division of technilab inc.
00430781
Liquid - Oral
100 %
11/15/1994
GLYCERIN LIQUID
d.c. labs limited
00094048
Liquid - Oral ,  Topical
null NIL / NIL
12/31/1951
HAND THERAPY CREME
beauticontrol inc.
02246586
Cream - Topical
28 %
8/1/2003
GLY-RECTAL SUP POUR ADULTES
lab valmo enregistré, division of technilab inc.
00484830
Suppository - Rectal
91 % / SUP
12/31/1979
GLYCERIN SUPPOSITORIES FOR ADULTS 90%
technilab pharma inc.
00145416
Suppository - Rectal
90 %
12/31/1978

CIMA AEMPS Drug Approvals

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Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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License Number
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Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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License Number
Dosage Form
Strength
Approval Date
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Malaysia NPRA Drug Approvals

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Approval Date
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UK EMC Drug Information

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Medicine Name
MA Holder
MA Number
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Active Ingredient
Authorization Date
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