FDA.reportPublic FDA data

Glycerin

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2018-12-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:51

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 two 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Glycerin Suppositories, 30 & 60 ct per case

Distributed by:

ATLANTIC BIOLOGICALS CORP. 

MIAMI, FL 33179

60ct60ct

30ct30ct

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0221-12020-01-31C16284748780-19d75b9d0-98e6-f424-e053-dadaa90a57ceGNP Glycerin Supp.
17856-0221-22020-01-31C16284748780-19d75b9d0-98e6-f424-e053-dadaa90a57ceGNP Glycerin Supp.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0221-1Glycerin1 in 1 POUCHSUPPOSITORY11
17856-0221-1Glycerin60 in 1 BOX, UNIT-DOSESUPPOSITORY601
17856-0221-2Glycerin1 in 1 POUCHSUPPOSITORY11
17856-0221-2Glycerin30 in 1 BOX, UNIT-DOSESUPPOSITORY301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0221GLYCERIN (GLYCERIN) SUPPOSITORY [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 4 package rows20181220_89b5d376-f8c6-4c86-9dd8-67d047d0d45b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-221-63EA - Each46122-221ef78bcd7-30bc-4df8-b7e5-bd3e8eb0978c12013-10-17
46122-221-71EA - Each46122-22112ac563a-74be-4ff3-8d4d-a32a1c80333512013-10-17

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
17856-022117856-0221-2, 17856-0221-1
46122-221

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
ndc (product): 46122-221
db8fe444-f975-4dfd-ac2d-279991fcd77189b5d376-f8c6-4c86-9dd8-67d047d0d45b2018-12-19WarningsExact identifier
spl id: db8fe444-f975-4dfd-ac2d-279991fcd771
spl set id: 89b5d376-f8c6-4c86-9dd8-67d047d0d45b

Reported adverse events (FAERS/openFDA)#

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