flonase headache and allergy relief

Generic: acetaminophen, chlorpheniramine maleate, phenylephrine hcl

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name flonase headache and allergy relief
Generic Name acetaminophen, chlorpheniramine maleate, phenylephrine hcl
Labeler haleon us holdings llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, chlorpheniramine maleate 2 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0578
Product ID 0135-0578_1599c55d-8de5-cc14-e063-6394a90aba82
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-03-10

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350578
Hyphenated Format 0135-0578

Supplemental Identifiers

RxCUI
1046781
UNII
362O9ITL9D V1Q0O9OJ9Z 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 flonase headache and allergy relief (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 2 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0135-0578-01) / 12 TABLET in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (0135-0578-02) / 48 TABLET in 1 BLISTER PACK
  • 8 BLISTER PACK in 1 CARTON (0135-0578-03) / 96 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

0135-0578-01 1 BLISTER PACK in 1 CARTON (0135-0578-01) / 12 TABLET in 1 BLISTER PACK 0135-0578-02 4 BLISTER PACK in 1 CARTON (0135-0578-02) / 48 TABLET in 1 BLISTER PACK 0135-0578-03 8 BLISTER PACK in 1 CARTON (0135-0578-03) / 96 TABLET in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) chlorpheniramine maleate (2 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

FLONASE Headache and Allergy Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1599c55d-8de5-cc14-e063-6394a90aba82", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "04JA59TNSJ"], "rxcui": ["1046781"], "spl_set_id": ["282c103c-3888-4a35-a5b1-d492ed6892c1"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0135-0578-01)  / 12 TABLET in 1 BLISTER PACK", "package_ndc": "0135-0578-01", "marketing_start_date": "20220310"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (0135-0578-02)  / 48 TABLET in 1 BLISTER PACK", "package_ndc": "0135-0578-02", "marketing_start_date": "20220310"}, {"sample": false, "description": "8 BLISTER PACK in 1 CARTON (0135-0578-03)  / 96 TABLET in 1 BLISTER PACK", "package_ndc": "0135-0578-03", "marketing_start_date": "20220310"}], "brand_name": "FLONASE Headache and Allergy Relief", "product_id": "0135-0578_1599c55d-8de5-cc14-e063-6394a90aba82", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0135-0578", "generic_name": "acetaminophen, chlorpheniramine maleate, phenylephrine hcl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "FLONASE", "brand_name_suffix": "Headache and Allergy Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "2 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220310", "listing_expiration_date": "20261231"}