fargelin hemorrhoidal

Generic: calamine, petrolatum and phenylephrine hydrochloride

Labeler: madison one acme inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name fargelin hemorrhoidal
Generic Name calamine, petrolatum and phenylephrine hydrochloride
Labeler madison one acme inc
Dosage Form OINTMENT
Routes
RECTAL TOPICAL
Active Ingredients

ferric oxide red .05 g/100g, petrolatum 79.25 g/100g, phenylephrine hydrochloride .25 g/100g, zinc oxide 10.3 g/100g

Manufacturer
MADISON ONE ACME INC

Identifiers & Regulatory

Product NDC 55614-610
Product ID 55614-610_43466548-41d6-9d96-e063-6294a90acd67
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2019-11-27

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55614610
Hyphenated Format 55614-610

Supplemental Identifiers

UNII
1K09F3G675 4T6H12BN9U 04JA59TNSJ SOI2LOH54Z

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 fargelin hemorrhoidal (source: ndc)
Generic Name calamine, petrolatum and phenylephrine hydrochloride (source: ndc)
Application Number M015 (source: ndc)
Routes
RECTAL TOPICAL
source: ndc

Resolved Composition

Strengths
  • .05 g/100g
  • 79.25 g/100g
  • .25 g/100g
  • 10.3 g/100g
source: ndc
Packaging
  • 20 g in 1 TUBE, WITH APPLICATOR (55614-610-01)
source: ndc

Packages (1)

55614-610-01 20 g in 1 TUBE, WITH APPLICATOR (55614-610-01)

Ingredients (4)

ferric oxide red (.05 g/100g) petrolatum (79.25 g/100g) phenylephrine hydrochloride (.25 g/100g) zinc oxide (10.3 g/100g)

Linked Drug Pages (1)

FARGELIN HEMORRHOIDAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL", "TOPICAL"], "spl_id": "43466548-41d6-9d96-e063-6294a90acd67", "openfda": {"unii": ["1K09F3G675", "4T6H12BN9U", "04JA59TNSJ", "SOI2LOH54Z"], "spl_set_id": ["6844ad63-512d-496a-9458-011894185b0d"], "manufacturer_name": ["MADISON ONE ACME INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 g in 1 TUBE, WITH APPLICATOR (55614-610-01)", "package_ndc": "55614-610-01", "marketing_start_date": "20191127"}], "brand_name": "FARGELIN HEMORRHOIDAL", "product_id": "55614-610_43466548-41d6-9d96-e063-6294a90acd67", "dosage_form": "OINTMENT", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "55614-610", "generic_name": "Calamine, Petrolatum and Phenylephrine hydrochloride", "labeler_name": "MADISON ONE ACME INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "FARGELIN HEMORRHOIDAL", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": ".05 g/100g"}, {"name": "PETROLATUM", "strength": "79.25 g/100g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": ".25 g/100g"}, {"name": "ZINC OXIDE", "strength": "10.3 g/100g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20191127", "listing_expiration_date": "20261231"}