Glycerin

Product NDC
57237-325
Requested package NDC
57237-325-52
11-digit product format
572370325
Labeler code
57237
Product ID
57237-325_89913e09-2a56-491c-9a36-77ef2c1f28fe
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
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN2 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
104155Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db539b39-9504-44d2-9bd5-ba6ffb441024Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-325-16Glycerin6 in 1 BLISTER PACKSUPPOSITORY64
57237-325-21Glycerin2 in 1 CARTONSUPPOSITORY24
57237-325-51Glycerin5 in 1 BLISTER PACKSUPPOSITORY54
57237-325-52Glycerin5 in 1 CARTONSUPPOSITORY54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-325-21EA - Each57237-325727d12ed-4dc6-43e3-9474-eff01b170ab912024-02-14
57237-325-52EA - Each57237-325112f7281-cc90-4bbe-8a9e-06e7248d2dfe12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-325GLYCERIN SUPPOSITORY [RISING PHARMA HOLDINGS, INC.]2Current NDC, 4 package rows20241103_db539b39-9504-44d2-9bd5-ba6ffb441024.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
GlycerinGLYCERINRising Pharma Holdings, Inc.db539b39-9504-44d2-9bd5-ba6ffb4410242025-09-08WarningsExact identifier
ndc (package): 57237-325-52
ndc (product): 57237-325
ndc11 (package): 57237032552

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104155glycerin 2 GM Rectal SuppositoryPSNdb539b39-9504-44d2-9bd5-ba6ffb4410244
104155glycerin 2000 MG Rectal SuppositorySCDdb539b39-9504-44d2-9bd5-ba6ffb4410244
104155glycerin 2 GM Rectal SuppositorySYdb539b39-9504-44d2-9bd5-ba6ffb4410244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-325-52572370325525 BLISTER PACK in 1 CARTON (57237-325-52) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-325-51) 5 blister pack2023-08-242026-11-30NoNoHistorical