FDA.reportPublic FDA data

Glycerin

Product NDC
83324-284
11-digit product format
833240284
Labeler code
83324
Product ID
83324-284_424d91bf-a81e-a627-e063-6294a90a3c3b
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Chain Drug Marketing Association Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-29
Substance
GLYCERIN
Active strength
2.1 g/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Glycerin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN2.1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
583084Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
424d91f0-ecf9-6d9b-e063-6394a90a8006Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-284-25Glycerin25 in 1 JARSUPPOSITORY251
83324-284-50Glycerin50 in 1 JARSUPPOSITORY501

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 42 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
application number: M007
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGAllegiant Health94a9c24a-07c3-4535-b810-b7abc9fc5ad52019-12-11WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGMarc Glassman, Inc.ec34fc1e-d122-4fa4-859e-e89e3e12edd52019-09-18WarningsExact identifier
application number: M007
Womens LaxativeBISACODYLMarc Glassman, Inc.aeb3c49b-cbf5-4a47-b19c-e77fbb987a492019-09-17WarningsExact identifier
application number: M007
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGAllegiant Health51f1c6c0-770c-4426-820b-bc1f42e143fd2019-02-07WarningsExact identifier
application number: M007
Senna-LaxSENNOSIDESMarc Glassman, Inc.7dd97c54-2ba1-4629-87b9-1ba0913fe5312016-12-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583084glycerin 2.1 GM Adult Rectal SuppositoryPSN424d91f0-ecf9-6d9b-e063-6394a90a80061
583084glycerin 2100 MG Rectal SuppositorySCD424d91f0-ecf9-6d9b-e063-6394a90a80061
583084glycerin 2.1 GM Rectal SuppositorySY424d91f0-ecf9-6d9b-e063-6394a90a80061
583084glycerin 82.5 % Adult Rectal SuppositorySY424d91f0-ecf9-6d9b-e063-6394a90a80061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-284-258332402842525 SUPPOSITORY in 1 JAR (83324-284-25) 25 suppository2025-10-29NoNoCurrent
83324-284-508332402845050 SUPPOSITORY in 1 JAR (83324-284-50) 50 suppository2025-10-29NoNoCurrent