simple promise simple h hemorrhoid relief cream

Generic: phenylephrine hydrochloride, pramoxine hydrochloride

Labeler: simple promise pte ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simple promise simple h hemorrhoid relief cream
Generic Name phenylephrine hydrochloride, pramoxine hydrochloride
Labeler simple promise pte ltd
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

phenylephrine hydrochloride 2.5 mg/g, pramoxine hydrochloride 10 mg/g

Manufacturer
SIMPLE PROMISE PTE LTD

Identifiers & Regulatory

Product NDC 83311-335
Product ID 83311-335_0976dfc5-c33b-11fe-e063-6294a90aa2bb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2023-03-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83311335
Hyphenated Format 83311-335

Supplemental Identifiers

RxCUI
1293856
UNII
04JA59TNSJ 88AYB867L5

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 simple promise simple h hemorrhoid relief cream (source: ndc)
Generic Name phenylephrine hydrochloride, pramoxine hydrochloride (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (83311-335-00) / 56.7 g in 1 TUBE
source: ndc

Packages (1)

83311-335-00 1 TUBE in 1 BOX (83311-335-00) / 56.7 g in 1 TUBE

Ingredients (2)

phenylephrine hydrochloride (2.5 mg/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

SIMPLE PROMISE Simple H Hemorrhoid Relief Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0976dfc5-c33b-11fe-e063-6294a90aa2bb", "openfda": {"unii": ["04JA59TNSJ", "88AYB867L5"], "rxcui": ["1293856"], "spl_set_id": ["f6622caa-3b31-9b07-e053-2a95a90a8a51"], "manufacturer_name": ["SIMPLE PROMISE PTE LTD"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (83311-335-00)  / 56.7 g in 1 TUBE", "package_ndc": "83311-335-00", "marketing_start_date": "20230306"}], "brand_name": "SIMPLE PROMISE Simple H Hemorrhoid Relief Cream", "product_id": "83311-335_0976dfc5-c33b-11fe-e063-6294a90aa2bb", "dosage_form": "CREAM", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "83311-335", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE", "labeler_name": "SIMPLE PROMISE PTE LTD", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SIMPLE PROMISE Simple H Hemorrhoid Relief Cream", "active_ingredients": [{"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": "20230306", "listing_expiration_date": "20261231"}