chest congestion relief

Generic: guaifenesin

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name chest congestion relief
Generic Name guaifenesin
Labeler rugby laboratories
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

guaifenesin 100 mg/5mL

Manufacturer
RUGBY LABORATORIES

Identifiers & Regulatory

Product NDC 0536-1314
Product ID 0536-1314_472e745d-bd02-5475-e063-6394a90a246f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-10-01

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 05361314
Hyphenated Format 0536-1314

Supplemental Identifiers

RxCUI
310604
UPC
0305361314859
UNII
495W7451VQ
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 chest congestion relief (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0536-1314-85)
source: ndc

Packages (1)

Ingredients (1)

guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "472e745d-bd02-5475-e063-6394a90a246f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0305361314859"], "unii": ["495W7451VQ"], "rxcui": ["310604"], "spl_set_id": ["51b088bc-b44f-44b9-a08e-133509a35a2c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RUGBY LABORATORIES"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0536-1314-85)", "package_ndc": "0536-1314-85", "marketing_start_date": "20201001"}], "brand_name": "Chest Congestion Relief", "product_id": "0536-1314_472e745d-bd02-5475-e063-6394a90a246f", "dosage_form": "LIQUID", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "0536-1314", "generic_name": "Guaifenesin", "labeler_name": "RUGBY LABORATORIES", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Chest Congestion Relief", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20201001", "listing_expiration_date": "20261231"}