hemorrhoidal

Generic: mineral oil, petrolatum, phenylephrine hcl

Labeler: bionpharma inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hemorrhoidal
Generic Name mineral oil, petrolatum, phenylephrine hcl
Labeler bionpharma inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

mineral oil 140 mg/g, petrolatum 749 mg/g, phenylephrine hydrochloride 2.5 mg/g

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-448
Product ID 69452-448_1790da99-2a23-e2a2-e063-6394a90ac36f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2025-04-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452448
Hyphenated Format 69452-448

Supplemental Identifiers

RxCUI
1372298
UNII
T5L8T28FGP 4T6H12BN9U 04JA59TNSJ

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 (source: ndc)
Generic Name mineral oil, petrolatum, phenylephrine hcl (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 140 mg/g
  • 749 mg/g
  • 2.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (69452-448-38) / 56 g in 1 TUBE
source: ndc

Packages (1)

69452-448-38 1 TUBE in 1 CARTON (69452-448-38) / 56 g in 1 TUBE

Ingredients (3)

mineral oil (140 mg/g) petrolatum (749 mg/g) phenylephrine hydrochloride (2.5 mg/g)

Linked Drug Pages (1)

hemorrhoidal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1790da99-2a23-e2a2-e063-6394a90ac36f", "openfda": {"unii": ["T5L8T28FGP", "4T6H12BN9U", "04JA59TNSJ"], "rxcui": ["1372298"], "spl_set_id": ["1790da99-2a22-e2a2-e063-6394a90ac36f"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69452-448-38)  / 56 g in 1 TUBE", "package_ndc": "69452-448-38", "marketing_start_date": "20250410"}], "brand_name": "hemorrhoidal", "product_id": "69452-448_1790da99-2a23-e2a2-e063-6394a90ac36f", "dosage_form": "OINTMENT", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "69452-448", "generic_name": "mineral oil, petrolatum, phenylephrine hcl", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "hemorrhoidal", "active_ingredients": [{"name": "MINERAL OIL", "strength": "140 mg/g"}, {"name": "PETROLATUM", "strength": "749 mg/g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250410", "listing_expiration_date": "20261231"}