FDA.reportPublic FDA data

Proctozone GMax

Product NDC
57237-339
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 Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX
Rxcui104155

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

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
57237-339-16572370339166 in 1 BLISTER PACKHistorical
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
57237-339-51572370339515 in 1 BLISTER PACKHistorical
57237-339-52572370339525 BLISTER PACK in 1 CARTON (57237-339-52) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-339-51) 5 blister pack2025-07-31NoNoCurrent