topcare hemorrhoidal

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

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare hemorrhoidal
Generic Name glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum
Labeler topco associates 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
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-944
Product ID 36800-944_ff52b31c-4839-455f-af93-e0ca45c09784
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2011-11-03

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 36800944
Hyphenated Format 36800-944

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 topcare hemorrhoidal (source: ndc)
Generic Name glycerin, phenylephrine hcl, pramoxine hcl, white 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 CARTON (36800-944-24) / 51 g in 1 TUBE
source: ndc

Packages (1)

36800-944-24 1 TUBE in 1 CARTON (36800-944-24) / 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)

topcare hemorrhoidal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ff52b31c-4839-455f-af93-e0ca45c09784", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["PDC6A3C0OX", "4T6H12BN9U", "04JA59TNSJ", "88AYB867L5"], "rxcui": ["1293649"], "spl_set_id": ["5e13da07-48cf-40bc-bb11-fd891886cbea"], "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": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (36800-944-24)  / 51 g in 1 TUBE", "package_ndc": "36800-944-24", "marketing_start_date": "20111103"}], "brand_name": "topcare hemorrhoidal", "product_id": "36800-944_ff52b31c-4839-455f-af93-e0ca45c09784", "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": "36800-944", "generic_name": "glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare hemorrhoidal", "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": "20111103", "listing_expiration_date": "20261231"}