mucus relief

Generic: guaifenesin

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

Drug Facts

Product Profile

Brand Name mucus relief
Generic Name guaifenesin
Labeler rugby laboratories
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 1200 mg/1

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1392
Product ID 0536-1392_2084ed1b-b468-48d7-bdb1-587fc6e5fd50
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207342
Marketing Start 2023-07-01
Marketing End 2026-10-28

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 05361392
Hyphenated Format 0536-1392

Supplemental Identifiers

RxCUI
310621
UPC
0305361392888
UNII
495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 mucus relief (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA207342 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/1
source: ndc
Packaging
  • 14 BLISTER PACK in 1 CARTON (0536-1392-88) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0536-1392-88 14 BLISTER PACK in 1 CARTON (0536-1392-88) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Mucus Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2084ed1b-b468-48d7-bdb1-587fc6e5fd50", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0305361392888"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["ee413595-2687-4c38-84ce-18aac933d8e3"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Rugby Laboratories"]}, "finished": true, "packaging": [{"sample": false, "description": "14 BLISTER PACK in 1 CARTON (0536-1392-88)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1392-88", "marketing_end_date": "20261028", "marketing_start_date": "20230701"}], "brand_name": "Mucus Relief", "product_id": "0536-1392_2084ed1b-b468-48d7-bdb1-587fc6e5fd50", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "0536-1392", "generic_name": "Guaifenesin", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA207342", "marketing_category": "ANDA", "marketing_end_date": "20261028", "marketing_start_date": "20230701"}