Glycerin

Manufacturer: Cosette Pharmaceuticals, Inc.
Effective date: 2019-08-13
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:15:36

Label at a glance#

ProductGlycerin

Active ingredientGLYCERIN

Label structure10 sections

Dosage and administration

adults and children 6 years and over 1 suppository per day or as directed by a doctor children 2 to under 6 years use pediatric glycerin suppositories children under 2 years ask a doctor • insert 1 suppository well up into rectum and retain for 15 minutes • it need not melt to produce laxative action

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Glycerin, USP 2.1 grams

PURPOSE

OTC - PURPOSE SECTION

Laxative

USE

INDICATIONS & USAGE SECTION

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 1/4 to 1 hour

WARNINGS

WARNINGS SECTION

For rectal use only
Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have
• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over 2 weeks

When using this product you may have rectal discomfort or a burning sensation

Stop use and ask a doctor if 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 and over	1 suppository per day or as directed by a doctor
children 2 to under 6 years	use pediatric glycerin suppositories
children under 2 years	ask a doctor

• insert 1 suppository well up into rectum and retain for 15 minutes
• it need not melt to produce laxative action

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• keep tightly closed
• avoid excessive heat

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

purified water, sodium hydroxide, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0713-0101-02
Glycerin Suppositories
Laxative
100 Adult Size

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0713-0101-02	EA - Each	0713-0101	664981fd-960b-4d1f-9027-9915050e1d75	1	2012-07-24
0713-0101-09	EA - Each	0713-0101	3bc62ce7-bd0a-4bdf-93d7-67531543b1c4	1	2012-07-24
0713-0101-13	EA - Each	0713-0101	e3ec21ac-b624-4423-b224-db12ea14f785	1	2012-07-24
0713-0101-25	EA - Each	0713-0101	56b92026-3076-4e41-b60b-c33bfea6f626	1	2012-07-24
0713-0101-26	EA - Each	0713-0101	98879708-82c2-4d34-8410-9dd1d57ca3bd	1	2012-07-24
0713-0101-51	EA - Each	0713-0101	40beba9e-fc22-490f-9dc7-bfd809b4b137	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Glycerin	ACTIVE INGREDIENT	PDC6A3C0OX	1
Glycerin	ACTIVE MOIETY	PDC6A3C0OX	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Glycerin
WATER
SODIUM HYDROXIDE
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0713-0101	0713-0101-02, 0713-0101-13, 0713-0101-25, 0713-0101-26, 0713-0101-51, 0713-0101-09

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
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	ACTIB
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 200 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-AMNIOTIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SPRAY / NASAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CONCENTRATE / ORAL	10 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	OINTMENT, AUGMENTED / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, LIQUID FILLED / ORAL	1.5 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SHAMPOO / TOPICAL		3 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / IRRIGATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CREAM / VAGINAL	0.19 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / TRANSDERMAL		472 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, EMULSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SYRUP / ORAL	71 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTERIAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVITREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAMUSCULAR		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ORAL		9 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	78.36 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / IONTOPHORESIS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		27 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADISCAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / RETROBULBAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SWAB / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	LOTION / TOPICAL		21 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ORAL	400 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVESICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b8fe76ad-925d-45ef-b9dd-ac563ca5afc8			267300ec-7522-ce46-3fe5-48469b5100a9	2021-06-29	Warnings	Exact identifier spl set id: 267300ec-7522-ce46-3fe5-48469b5100a9

Reported adverse events (FAERS/openFDA)#

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