FDA.reportPublic FDA data

Glycerin

Product NDC
57237-326
11-digit product format
572370326
Labeler code
57237
Product ID
57237-326_df6d112b-3323-4d91-9095-f6f933368427
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Rising Pharma Holdings, Inc.
Application
M007.54
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-24
Marketing end
2026-11-30
Substance
GLYCERIN
Active strength
1.2 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glycerin
Brand name suffix
Children

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN1.2 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
421299Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
80a5a944-2882-4f8d-a955-ef827cead5f0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-326-16GlycerinChildren6 in 1 BLISTER PACKSUPPOSITORY64
57237-326-21GlycerinChildren2 in 1 CARTONSUPPOSITORY24
57237-326-51GlycerinChildren5 in 1 BLISTER PACKSUPPOSITORY54
57237-326-52GlycerinChildren5 in 1 CARTONSUPPOSITORY54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-326-21EA - Each57237-32673646dd8-a414-4d46-a8ef-3123a1653c8a12024-02-14
57237-326-52EA - Each57237-32678189046-fd71-44ff-b0ad-1fe964beafdf12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-326GLYCERIN CHILDREN (GLYCERIN) SUPPOSITORY [RISING PHARMA HOLDINGS, INC.]2Current NDC, 4 package rows20241103_80a5a944-2882-4f8d-a955-ef827cead5f0.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glycerin ChildrenGLYCERINRising Pharma Holdings, Inc.80a5a944-2882-4f8d-a955-ef827cead5f02025-09-08WarningsExact identifier
ndc (product): 57237-326

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
421299glycerin 1.2 GM Pediatric Rectal SuppositoryPSN80a5a944-2882-4f8d-a955-ef827cead5f04
421299glycerin 1200 MG Rectal SuppositorySCD80a5a944-2882-4f8d-a955-ef827cead5f04
421299glycerin 1.2 GM Rectal SuppositorySY80a5a944-2882-4f8d-a955-ef827cead5f04
421299glycerin 82.5 % Pediatric Rectal SuppositorySY80a5a944-2882-4f8d-a955-ef827cead5f04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-326-16572370326166 in 1 BLISTER PACKHistorical
57237-326-21572370326212 BLISTER PACK in 1 CARTON (57237-326-21) / 6 SUPPOSITORY in 1 BLISTER PACK (57237-326-16) 2 blister pack2023-08-242026-11-30NoNoHistorical
57237-326-51572370326515 in 1 BLISTER PACKHistorical
57237-326-52572370326525 BLISTER PACK in 1 CARTON (57237-326-52) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-326-51) 5 blister pack2023-08-242026-11-30NoNoHistorical