hemorroidal cooling gel

Generic: phenylephrine, witch hazel

Labeler: pharmacy value alliance, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hemorroidal cooling gel
Generic Name phenylephrine, witch hazel
Labeler pharmacy value alliance, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

phenylephrine hydrochloride .25 g/100g, witch hazel .5 g/100g

Manufacturer
Pharmacy Value Alliance, LLC

Identifiers & Regulatory

Product NDC 68016-054
Product ID 68016-054_29b73242-ddd9-37e0-e063-6394a90a7da9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2018-08-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68016054
Hyphenated Format 68016-054

Supplemental Identifiers

UNII
04JA59TNSJ 101I4J0U34

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 hemorroidal cooling gel (source: ndc)
Generic Name phenylephrine, witch hazel (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 g/100g
  • .5 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (68016-054-09) / 26 g in 1 TUBE
source: ndc

Packages (1)

68016-054-09 1 TUBE in 1 BOX (68016-054-09) / 26 g in 1 TUBE

Ingredients (2)

phenylephrine hydrochloride (.25 g/100g) witch hazel (.5 g/100g)

Linked Drug Pages (1)

Hemorroidal Cooling gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "29b73242-ddd9-37e0-e063-6394a90a7da9", "openfda": {"unii": ["04JA59TNSJ", "101I4J0U34"], "spl_set_id": ["7276aab8-0297-2a55-e053-2a91aa0a8d21"], "manufacturer_name": ["Pharmacy Value Alliance, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (68016-054-09)  / 26 g in 1 TUBE", "package_ndc": "68016-054-09", "marketing_start_date": "20180802"}], "brand_name": "Hemorroidal Cooling gel", "product_id": "68016-054_29b73242-ddd9-37e0-e063-6394a90a7da9", "dosage_form": "GEL", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "68016-054", "generic_name": "Phenylephrine, Witch Hazel", "labeler_name": "Pharmacy Value Alliance, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hemorroidal Cooling gel", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": ".25 g/100g"}, {"name": "WITCH HAZEL", "strength": ".5 g/100g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180802", "listing_expiration_date": "20261231"}