rynex pe

Generic: brompheniramine maleate and phenylephrine hcl

Labeler: edwards pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name rynex pe
Generic Name brompheniramine maleate and phenylephrine hcl
Labeler edwards pharmaceuticals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

brompheniramine maleate 1 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
EDWARDS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 0485-0202
Product ID 0485-0202_4c481ad3-2e51-1c12-e063-6294a90a4b6b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2011-03-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04850202
Hyphenated Format 0485-0202

Supplemental Identifiers

RxCUI
1053258
UNII
IXA7C9ZN03 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 rynex pe (source: ndc)
Generic Name brompheniramine maleate and phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (0485-0202-16)
source: ndc

Packages (1)

0485-0202-16 473 mL in 1 BOTTLE, PLASTIC (0485-0202-16)

Ingredients (2)

brompheniramine maleate (1 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

RYNEX PE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c481ad3-2e51-1c12-e063-6294a90a4b6b", "openfda": {"unii": ["IXA7C9ZN03", "04JA59TNSJ"], "rxcui": ["1053258"], "spl_set_id": ["77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef"], "manufacturer_name": ["EDWARDS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0485-0202-16)", "package_ndc": "0485-0202-16", "marketing_start_date": "20110307"}], "brand_name": "RYNEX PE", "product_id": "0485-0202_4c481ad3-2e51-1c12-e063-6294a90a4b6b", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0485-0202", "generic_name": "BROMPHENIRAMINE MALEATE and Phenylephrine HCL", "labeler_name": "EDWARDS PHARMACEUTICALS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "RYNEX PE", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20110307", "listing_expiration_date": "20271231"}