nasal decongestant pe

Generic: phenylephrine hydrochloride

Labeler: hhh pharma usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nasal decongestant pe
Generic Name phenylephrine hydrochloride
Labeler hhh pharma usa llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phenylephrine hydrochloride 10 mg/1

Manufacturer
HHH PHARMA USA LLC

Identifiers & Regulatory

Product NDC 83586-160
Product ID 83586-160_3af83f12-c1cb-5273-e063-6394a90af7c3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-07-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83586160
Hyphenated Format 83586-160

Supplemental Identifiers

RxCUI
1049182
UPC
0383586160017
UNII
04JA59TNSJ

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 nasal decongestant pe (source: ndc)
Generic Name phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (83586-160-01)
source: ndc

Packages (1)

83586-160-01 100 TABLET in 1 BOTTLE (83586-160-01)

Ingredients (1)

phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Nasal Decongestant PE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3af83f12-c1cb-5273-e063-6394a90af7c3", "openfda": {"upc": ["0383586160017"], "unii": ["04JA59TNSJ"], "rxcui": ["1049182"], "spl_set_id": ["90fae0fa-da07-4ea8-bdbd-39c2ed99ae59"], "manufacturer_name": ["HHH PHARMA USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (83586-160-01)", "package_ndc": "83586-160-01", "marketing_start_date": "20250728"}], "brand_name": "Nasal Decongestant PE", "product_id": "83586-160_3af83f12-c1cb-5273-e063-6394a90af7c3", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "83586-160", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "HHH PHARMA USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nasal Decongestant PE", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250728", "listing_expiration_date": "20261231"}