0.25 % phenylephrine hcl hemorrhoidal

Generic: mineral oil, petrolatum, phenylephrine hydrochloride

Labeler: universal distribution center llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name 0.25 % phenylephrine hcl hemorrhoidal
Generic Name mineral oil, petrolatum, phenylephrine hydrochloride
Labeler universal distribution center llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

mineral oil 14 g/100g, petrolatum 74.9 g/100g, phenylephrine hydrochloride .25 g/100g

Manufacturer
Universal Distribution Center LLC

Identifiers & Regulatory

Product NDC 52000-438
Product ID 52000-438_22df9c1b-c87e-46e8-a9f5-6a03e7549253
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2027-12-31
Marketing Start 2026-01-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52000438
Hyphenated Format 52000-438

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 0.25 % phenylephrine hcl hemorrhoidal (source: ndc)
Generic Name mineral oil, petrolatum, phenylephrine hydrochloride (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 14 g/100g
  • 74.9 g/100g
  • .25 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (52000-438-02) / 57 g in 1 TUBE
source: ndc

Packages (1)

52000-438-02 1 TUBE in 1 BOX (52000-438-02) / 57 g in 1 TUBE

Ingredients (3)

mineral oil (14 g/100g) petrolatum (74.9 g/100g) phenylephrine hydrochloride (.25 g/100g)

Linked Drug Pages (1)

0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "22df9c1b-c87e-46e8-a9f5-6a03e7549253", "openfda": {"unii": ["T5L8T28FGP", "4T6H12BN9U", "04JA59TNSJ"], "rxcui": ["1372298"], "spl_set_id": ["90844919-f16a-4390-9dca-b0405b501445"], "manufacturer_name": ["Universal Distribution Center LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (52000-438-02)  / 57 g in 1 TUBE", "package_ndc": "52000-438-02", "marketing_start_date": "20260119"}], "brand_name": "0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL", "product_id": "52000-438_22df9c1b-c87e-46e8-a9f5-6a03e7549253", "dosage_form": "OINTMENT", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "52000-438", "generic_name": "Mineral Oil, Petrolatum, Phenylephrine Hydrochloride", "labeler_name": "Universal Distribution Center LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL", "active_ingredients": [{"name": "MINERAL OIL", "strength": "14 g/100g"}, {"name": "PETROLATUM", "strength": "74.9 g/100g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": ".25 g/100g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260119", "listing_expiration_date": "20271231"}