mucus relief er

Generic: guaifenesin

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

Drug Facts

Product Profile

Brand Name mucus relief er
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 0536-1249
Product ID 0536-1249_3b5fbc86-cb0e-468d-e063-6394a90a811f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217780
Listing Expiration 2026-12-31
Marketing Start 2025-04-21

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 05361249
Hyphenated Format 0536-1249

Supplemental Identifiers

RxCUI
310621
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 mucus relief er (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA217780 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0536-1249-71) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3b5fbc86-cb0e-468d-e063-6394a90a811f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["2e6901aa-16f6-9b73-e063-6294a90a4d72"], "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": "2 BLISTER PACK in 1 CARTON (0536-1249-71)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1249-71", "marketing_start_date": "20250421"}], "brand_name": "Mucus Relief ER", "product_id": "0536-1249_3b5fbc86-cb0e-468d-e063-6394a90a811f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "0536-1249", "generic_name": "Guaifenesin", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief ER", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA217780", "marketing_category": "ANDA", "marketing_start_date": "20250421", "listing_expiration_date": "20261231"}