mucinex d

Generic: guaifenesin and pseudoephedrine hydrochloride

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucinex d
Generic Name guaifenesin and pseudoephedrine hydrochloride
Labeler rb health (us) llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1, pseudoephedrine hydrochloride 60 mg/1

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-057
Product ID 63824-057_30dff058-07d6-63b5-e063-6294a90ad81f
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021585
Listing Expiration 2026-12-31
Marketing Start 2012-06-26

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 63824057
Hyphenated Format 63824-057

Supplemental Identifiers

RxCUI
1305603
UPC
0363824057187
UNII
495W7451VQ 6V9V2RYJ8N
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 mucinex d (source: ndc)
Generic Name guaifenesin and pseudoephedrine hydrochloride (source: ndc)
Application Number NDA021585 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
  • 60 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (63824-057-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (63824-057-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

63824-057-18 1 BLISTER PACK in 1 CARTON (63824-057-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-057-36 4 BLISTER PACK in 1 CARTON (63824-057-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

guaifenesin (600 mg/1) pseudoephedrine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Mucinex D ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30dff058-07d6-63b5-e063-6294a90ad81f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0363824057187"], "unii": ["495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1305603"], "spl_set_id": ["d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63824-057-18)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-057-18", "marketing_start_date": "20120626"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63824-057-36)  / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-057-36", "marketing_start_date": "20120626"}], "brand_name": "Mucinex D", "product_id": "63824-057_30dff058-07d6-63b5-e063-6294a90ad81f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "63824-057", "generic_name": "Guaifenesin and Pseudoephedrine Hydrochloride", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucinex D", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "NDA021585", "marketing_category": "NDA", "marketing_start_date": "20120626", "listing_expiration_date": "20261231"}