mucus relief

Generic: guaifenesin

Labeler: aaa pharmaceutical, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucus relief
Generic Name guaifenesin
Labeler aaa pharmaceutical, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
AAA Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 57344-203
Product ID 57344-203_1acb86a4-a4a9-7ccc-e063-6294a90a67ed
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213420
Listing Expiration 2026-12-31
Marketing Start 2024-02-01

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 57344203
Hyphenated Format 57344-203

Supplemental Identifiers

RxCUI
636522
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 (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA213420 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (57344-203-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

57344-203-02 2 BLISTER PACK in 1 CARTON (57344-203-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (600 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": "1acb86a4-a4a9-7ccc-e063-6294a90a67ed", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["68d6b88a-85ed-414d-8369-c7cceb8e9780"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["AAA Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (57344-203-02)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "57344-203-02", "marketing_start_date": "20240201"}], "brand_name": "Mucus Relief", "product_id": "57344-203_1acb86a4-a4a9-7ccc-e063-6294a90a67ed", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "57344-203", "generic_name": "Guaifenesin", "labeler_name": "AAA Pharmaceutical, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA213420", "marketing_category": "ANDA", "marketing_start_date": "20240201", "listing_expiration_date": "20261231"}