proctozone gmax

Generic: glycerin

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name proctozone gmax
Generic Name glycerin
Labeler rising pharma holdings, inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

glycerin 2 g/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-339
Product ID 57237-339_8e27aa33-f09a-42d8-8cfe-efe6ca44f9b4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M007.54
Listing Expiration 2027-12-31
Marketing Start 2025-07-31

Pharmacologic Class

Established (EPC)
non-standardized chemical allergen [epc]
Chemical Structure
allergens [cs] glycerol [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57237339
Hyphenated Format 57237-339

Supplemental Identifiers

RxCUI
104155
UPC
0357237339527
UNII
PDC6A3C0OX
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name proctozone gmax (source: ndc)
Generic Name glycerin (source: ndc)
Application Number M007.54 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 2 g/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (57237-339-21) / 6 SUPPOSITORY in 1 BLISTER PACK (57237-339-16)
  • 5 BLISTER PACK in 1 CARTON (57237-339-52) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-339-51)
source: ndc

Packages (2)

57237-339-21 2 BLISTER PACK in 1 CARTON (57237-339-21) / 6 SUPPOSITORY in 1 BLISTER PACK (57237-339-16) 57237-339-52 5 BLISTER PACK in 1 CARTON (57237-339-52) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-339-51)

Ingredients (1)

glycerin (2 g/1)

Linked Drug Pages (1)

Proctozone GMax ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "8e27aa33-f09a-42d8-8cfe-efe6ca44f9b4", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "upc": ["0357237339527"], "unii": ["PDC6A3C0OX"], "rxcui": ["104155"], "spl_set_id": ["a13c2be6-d650-4b53-bddd-d55e92fe10c6"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (57237-339-21)  / 6 SUPPOSITORY in 1 BLISTER PACK (57237-339-16)", "package_ndc": "57237-339-21", "marketing_start_date": "20250731"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (57237-339-52)  / 5 SUPPOSITORY in 1 BLISTER PACK (57237-339-51)", "package_ndc": "57237-339-52", "marketing_start_date": "20250731"}], "brand_name": "Proctozone GMax", "product_id": "57237-339_8e27aa33-f09a-42d8-8cfe-efe6ca44f9b4", "dosage_form": "SUPPOSITORY", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]"], "product_ndc": "57237-339", "generic_name": "Glycerin", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Proctozone GMax", "active_ingredients": [{"name": "GLYCERIN", "strength": "2 g/1"}], "application_number": "M007.54", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250731", "listing_expiration_date": "20271231"}