mucus relief 600 mg

Generic: guaifenesin

Labeler: guardian drug company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucus relief 600 mg
Generic Name guaifenesin
Labeler guardian drug company
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
Guardian Drug Company

Identifiers & Regulatory

Product NDC 53041-190
Product ID 53041-190_2ad8b5c2-9495-4ba0-886b-b5f13484aef1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209215
Listing Expiration 2026-12-31
Marketing Start 2020-06-24

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 53041190
Hyphenated Format 53041-190

Supplemental Identifiers

RxCUI
310621 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 600 mg (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA209215 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-190-16)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-190-20)
  • 2 BLISTER PACK in 1 CARTON (53041-190-32) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (53041-190-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (4)

53041-190-16 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-190-16) 53041-190-20 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-190-20) 53041-190-32 2 BLISTER PACK in 1 CARTON (53041-190-32) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 53041-190-38 4 BLISTER PACK in 1 CARTON (53041-190-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Mucus Relief 600 mg, Mucus Relief Maximum Strength 1200 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2ad8b5c2-9495-4ba0-886b-b5f13484aef1", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621", "636522"], "spl_set_id": ["e7742a43-9066-4e28-a90d-f07c0e18f045"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-190-16)", "package_ndc": "53041-190-16", "marketing_start_date": "20200624"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-190-20)", "package_ndc": "53041-190-20", "marketing_start_date": "20200624"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (53041-190-32)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "53041-190-32", "marketing_start_date": "20200624"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (53041-190-38)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "53041-190-38", "marketing_start_date": "20200624"}], "brand_name": "Mucus Relief 600 mg", "product_id": "53041-190_2ad8b5c2-9495-4ba0-886b-b5f13484aef1", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "53041-190", "generic_name": "Guaifenesin", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief 600 mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA209215", "marketing_category": "ANDA", "marketing_start_date": "20200624", "listing_expiration_date": "20261231"}