hemorrhoidal cream

Generic: glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hemorrhoidal cream
Generic Name glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum
Labeler cardinal health 110, llc. dba leader
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

glycerin 4.032 g/28g, petrolatum 4.2 g/28g, phenylephrine hydrochloride .07 g/28g, pramoxine hydrochloride .28 g/28g

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0425
Product ID 70000-0425_0884bc8d-70d0-80db-e063-6294a90a6582
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2020-12-30

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 700000425
Hyphenated Format 70000-0425

Supplemental Identifiers

RxCUI
1293649
UPC
0096295135503
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 glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 4.032 g/28g
  • 4.2 g/28g
  • .07 g/28g
  • .28 g/28g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (70000-0425-1) / 28 g in 1 TUBE
source: ndc

Packages (1)

Ingredients (4)

glycerin (4.032 g/28g) petrolatum (4.2 g/28g) phenylephrine hydrochloride (.07 g/28g) pramoxine hydrochloride (.28 g/28g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "0884bc8d-70d0-80db-e063-6294a90a6582", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "upc": ["0096295135503"], "unii": ["PDC6A3C0OX", "4T6H12BN9U", "04JA59TNSJ", "88AYB867L5"], "rxcui": ["1293649"], "spl_set_id": ["85a51d5c-679e-1959-e053-2a91aa0a76d5"], "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": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (70000-0425-1)  / 28 g in 1 TUBE", "package_ndc": "70000-0425-1", "marketing_start_date": "20201230"}], "brand_name": "Hemorrhoidal Cream", "product_id": "70000-0425_0884bc8d-70d0-80db-e063-6294a90a6582", "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": "70000-0425", "generic_name": "Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, White Petrolatum", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hemorrhoidal Cream", "active_ingredients": [{"name": "GLYCERIN", "strength": "4.032 g/28g"}, {"name": "PETROLATUM", "strength": "4.2 g/28g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": ".07 g/28g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": ".28 g/28g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20201230", "listing_expiration_date": "20261231"}