mucus relief

Generic: guaifenesin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucus relief
Generic Name guaifenesin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-499
Product ID 71610-499_349de2f9-ec60-43d7-990a-074c673aa7e3
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209215
Listing Expiration 2026-12-31
Marketing Start 2019-09-23

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 71610499
Hyphenated Format 71610-499

Supplemental Identifiers

RxCUI
636522
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 ANDA209215 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 12 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-12)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-53)
source: ndc

Packages (2)

71610-499-12 12 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-12) 71610-499-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-53)

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": "349de2f9-ec60-43d7-990a-074c673aa7e3", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["01af03f1-5d1b-4893-b7db-7092ba66e842"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-12)", "package_ndc": "71610-499-12", "marketing_start_date": "20210416"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-53)", "package_ndc": "71610-499-53", "marketing_start_date": "20201120"}], "brand_name": "Mucus Relief", "product_id": "71610-499_349de2f9-ec60-43d7-990a-074c673aa7e3", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "71610-499", "generic_name": "Guaifenesin", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA209215", "marketing_category": "ANDA", "marketing_start_date": "20190923", "listing_expiration_date": "20261231"}