drx choice childrens stuffy nose and chest congestion

Generic: guaifenesin and phenylephrine hcl

Labeler: raritan pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name drx choice childrens stuffy nose and chest congestion
Generic Name guaifenesin and phenylephrine hcl
Labeler raritan pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

guaifenesin 100 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
RARITAN PHARMACEUTICALS

Identifiers & Regulatory

Product NDC 68163-748
Product ID 68163-748_3fef0ee0-c60c-a9de-e063-6394a90a99d6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-04-24

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 68163748
Hyphenated Format 68163-748

Supplemental Identifiers

RxCUI
1485599
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 drx choice childrens stuffy nose and chest congestion (source: ndc)
Generic Name guaifenesin and phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68163-748-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

68163-748-04 1 BOTTLE in 1 CARTON (68163-748-04) / 118 mL in 1 BOTTLE

Ingredients (2)

guaifenesin (100 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

DRx Choice Childrens Stuffy Nose and Chest Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3fef0ee0-c60c-a9de-e063-6394a90a99d6", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ", "04JA59TNSJ"], "rxcui": ["1485599"], "spl_set_id": ["7a3bb739-ff50-4d29-b270-d6b084906493"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RARITAN PHARMACEUTICALS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68163-748-04)  / 118 mL in 1 BOTTLE", "package_ndc": "68163-748-04", "marketing_start_date": "20230424"}], "brand_name": "DRx Choice Childrens Stuffy Nose and Chest Congestion", "product_id": "68163-748_3fef0ee0-c60c-a9de-e063-6394a90a99d6", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "68163-748", "generic_name": "Guaifenesin and Phenylephrine Hcl", "labeler_name": "RARITAN PHARMACEUTICALS", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DRx Choice Childrens Stuffy Nose and Chest Congestion", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "100 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230424", "listing_expiration_date": "20261231"}