thera plus hemorrhoidal

Generic: glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride

Labeler: fourstar group usa, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name thera plus hemorrhoidal
Generic Name glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride
Labeler fourstar group usa, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

glycerin 144 mg/g, petrolatum 150 mg/g, phenylephrine hydrochloride 2.5 mg/g, pramoxine hydrochloride 10 mg/g

Manufacturer
FOURSTAR GROUP USA, INC.

Identifiers & Regulatory

Product NDC 80684-141
Product ID 80684-141_2f86f571-1751-82b2-e063-6394a90afd28
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2025-03-03

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 80684141
Hyphenated Format 80684-141

Supplemental Identifiers

RxCUI
1293649
UPC
0049696700429
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 thera plus hemorrhoidal (source: ndc)
Generic Name glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 144 mg/g
  • 150 mg/g
  • 2.5 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 26 g in 1 TUBE (80684-141-00)
source: ndc

Packages (1)

80684-141-00 26 g in 1 TUBE (80684-141-00)

Ingredients (4)

glycerin (144 mg/g) petrolatum (150 mg/g) phenylephrine hydrochloride (2.5 mg/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Thera Plus Hemorrhoidal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2f86f571-1751-82b2-e063-6394a90afd28", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "upc": ["0049696700429"], "unii": ["PDC6A3C0OX", "4T6H12BN9U", "04JA59TNSJ", "88AYB867L5"], "rxcui": ["1293649"], "spl_set_id": ["87143a7a-7b2d-4b67-afda-2355697e7300"], "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": ["FOURSTAR GROUP USA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "26 g in 1 TUBE (80684-141-00)", "package_ndc": "80684-141-00", "marketing_start_date": "20250303"}], "brand_name": "Thera Plus Hemorrhoidal", "product_id": "80684-141_2f86f571-1751-82b2-e063-6394a90afd28", "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": "80684-141", "generic_name": "GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE", "labeler_name": "FOURSTAR GROUP USA, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Thera Plus Hemorrhoidal", "active_ingredients": [{"name": "GLYCERIN", "strength": "144 mg/g"}, {"name": "PETROLATUM", "strength": "150 mg/g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250303", "listing_expiration_date": "20261231"}