hemorrhoidal cream

Generic: glycerol, phenylephine, pramoxine, petrolatum

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hemorrhoidal cream
Generic Name glycerol, phenylephine, pramoxine, petrolatum
Labeler trifecta pharmaceuticals usa llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

glycerin 14.4 g/100g, petrolatum 15 g/100g, phenylephrine hydrochloride .25 g/100g, pramoxine hydrochloride 1 g/100g

Manufacturer
Trifecta Pharmaceuticals Usa Llc

Identifiers & Regulatory

Product NDC 69396-033
Product ID 69396-033_43e0c50f-9d84-3f1c-e063-6394a90a9a23
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2019-01-25

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 69396033
Hyphenated Format 69396-033

Supplemental Identifiers

RxCUI
1293649
UNII
PDC6A3C0OX 4T6H12BN9U 04JA59TNSJ 88AYB867L5
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 hemorrhoidal cream (source: ndc)
Generic Name glycerol, phenylephine, pramoxine, petrolatum (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 14.4 g/100g
  • 15 g/100g
  • .25 g/100g
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (69396-033-18) / 51 g in 1 TUBE
  • 2 TUBE in 1 BOX (69396-033-22) / 51 g in 1 TUBE
  • 3 TUBE in 1 BOX (69396-033-33) / 51 g in 1 TUBE
source: ndc

Packages (3)

69396-033-18 1 TUBE in 1 BOX (69396-033-18) / 51 g in 1 TUBE 69396-033-22 2 TUBE in 1 BOX (69396-033-22) / 51 g in 1 TUBE 69396-033-33 3 TUBE in 1 BOX (69396-033-33) / 51 g in 1 TUBE

Ingredients (4)

glycerin (14.4 g/100g) petrolatum (15 g/100g) phenylephrine hydrochloride (.25 g/100g) pramoxine hydrochloride (1 g/100g)

Linked Drug Pages (1)

Hemorrhoidal Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "43e0c50f-9d84-3f1c-e063-6394a90a9a23", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["PDC6A3C0OX", "4T6H12BN9U", "04JA59TNSJ", "88AYB867L5"], "rxcui": ["1293649"], "spl_set_id": ["804d7b1f-1be8-50c9-e053-2a91aa0a35d0"], "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": ["Trifecta Pharmaceuticals Usa Llc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-033-18)  / 51 g in 1 TUBE", "package_ndc": "69396-033-18", "marketing_start_date": "20190125"}, {"sample": false, "description": "2 TUBE in 1 BOX (69396-033-22)  / 51 g in 1 TUBE", "package_ndc": "69396-033-22", "marketing_start_date": "20250823"}, {"sample": false, "description": "3 TUBE in 1 BOX (69396-033-33)  / 51 g in 1 TUBE", "package_ndc": "69396-033-33", "marketing_start_date": "20240614"}], "brand_name": "Hemorrhoidal Cream", "product_id": "69396-033_43e0c50f-9d84-3f1c-e063-6394a90a9a23", "dosage_form": "CREAM", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "69396-033", "generic_name": "Glycerol, Phenylephine, Pramoxine, Petrolatum", "labeler_name": "Trifecta Pharmaceuticals Usa Llc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hemorrhoidal Cream", "active_ingredients": [{"name": "GLYCERIN", "strength": "14.4 g/100g"}, {"name": "PETROLATUM", "strength": "15 g/100g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": ".25 g/100g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "1 g/100g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190125", "listing_expiration_date": "20261231"}