FDA.reportPublic FDA data

Proctozone GMax

Product NDC
57237-339
Requested package NDC
57237-339-21
11-digit product format
572370339
Labeler code
57237
Product ID
57237-339_8e27aa33-f09a-42d8-8cfe-efe6ca44f9b4
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
2025-07-31
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
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Proctozone GMax
Listing expiration
2027-12-31

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
a13c2be6-d650-4b53-bddd-d55e92fe10c6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-339-16Proctozone GMax6 in 1 BLISTER PACKSUPPOSITORY62
57237-339-21Proctozone GMax2 in 1 CARTONSUPPOSITORY22
57237-339-51Proctozone GMax5 in 1 BLISTER PACKSUPPOSITORY52
57237-339-52Proctozone GMax5 in 1 CARTONSUPPOSITORY52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-339-16EA - Each57237-3398d94a140-015d-44f7-8f75-13551bd8576512026-04-20
57237-339-21EA - Each57237-3390d4a94b4-790e-4bda-957a-49d320c74e0b12025-11-13
57237-339-51EA - Each57237-33978bf1995-d145-48c5-8630-6dac1b54d64a12026-04-20
57237-339-52EA - Each57237-3396fd65dad-1070-43dc-8422-2c401a7d3e5f12026-03-17

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
Proctozone GMaxGLYCERINRising Pharma Holdings, Inc.a13c2be6-d650-4b53-bddd-d55e92fe10c62026-01-06WarningsExact identifier
ndc (package): 57237-339-21
ndc (product): 57237-339
ndc11 (package): 57237033921

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104155glycerin 2 GM Rectal SuppositoryPSNa13c2be6-d650-4b53-bddd-d55e92fe10c62
104155glycerin 2000 MG Rectal SuppositorySCDa13c2be6-d650-4b53-bddd-d55e92fe10c62
104155glycerin 2 GM Rectal SuppositorySYa13c2be6-d650-4b53-bddd-d55e92fe10c62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-339-21572370339212 BLISTER PACK in 1 CARTON (57237-339-21) / 6 SUPPOSITORY in 1 BLISTER PACK (57237-339-16) 2 blister pack2025-07-31NoNoCurrent