supress-pe pediatric

Generic: guiafenesin, phenylephrine hcl

Labeler: kramer novis
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name supress-pe pediatric
Generic Name guiafenesin, phenylephrine hcl
Labeler kramer novis
Dosage Form SOLUTION/ DROPS
Routes
ORAL
Active Ingredients

guaifenesin 50 mg/mL, phenylephrine hydrochloride 2.5 mg/mL

Manufacturer
Kramer Novis

Identifiers & Regulatory

Product NDC 52083-056
Product ID 52083-056_e99c9cb7-48a2-4115-8c61-4f7a0a9942bf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-01-14

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52083056
Hyphenated Format 52083-056

Supplemental Identifiers

RxCUI
824600
UPC
0352083056017
UNII
495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 supress-pe pediatric (source: ndc)
Generic Name guiafenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
  • 2.5 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, DROPPER (52083-056-01)
source: ndc

Packages (1)

52083-056-01 30 mL in 1 BOTTLE, DROPPER (52083-056-01)

Ingredients (2)

guaifenesin (50 mg/mL) phenylephrine hydrochloride (2.5 mg/mL)

Linked Drug Pages (1)

SUPRESS-PE Pediatric ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e99c9cb7-48a2-4115-8c61-4f7a0a9942bf", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0352083056017"], "unii": ["495W7451VQ", "04JA59TNSJ"], "rxcui": ["824600"], "spl_set_id": ["a474171d-5c29-4a80-9d37-00613796211a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Kramer Novis"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, DROPPER (52083-056-01)", "package_ndc": "52083-056-01", "marketing_start_date": "20140114"}], "brand_name": "SUPRESS-PE Pediatric", "product_id": "52083-056_e99c9cb7-48a2-4115-8c61-4f7a0a9942bf", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "52083-056", "generic_name": "Guiafenesin, Phenylephrine HCl", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SUPRESS-PE", "brand_name_suffix": "Pediatric", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "50 mg/mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140114", "listing_expiration_date": "20261231"}