mucinex maximum strength

Generic: guaifenesin

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

Drug Facts

Product Profile

Brand Name mucinex maximum strength
Generic Name guaifenesin
Labeler rb health (us) llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 1200 mg/1

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-023
Product ID 63824-023_32471226-a16f-5531-e063-6394a90a382f
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021282
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 63824023
Hyphenated Format 63824-023

Supplemental Identifiers

RxCUI
310621 891297
UPC
0363824023144
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 mucinex maximum strength (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number NDA021282 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (63824-023-02) / 1 TABLET, EXTENDED RELEASE in 1 POUCH
  • 1 BLISTER PACK in 1 CARTON (63824-023-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (63824-023-35) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (63824-023-36) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (63824-023-46) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (63824-023-48) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (63824-023-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (7)

63824-023-02 1 POUCH in 1 CARTON (63824-023-02) / 1 TABLET, EXTENDED RELEASE in 1 POUCH 63824-023-07 1 BLISTER PACK in 1 CARTON (63824-023-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-023-35 1 BLISTER PACK in 1 CARTON (63824-023-35) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-023-36 2 BLISTER PACK in 1 CARTON (63824-023-36) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-023-46 3 BLISTER PACK in 1 CARTON (63824-023-46) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-023-48 4 BLISTER PACK in 1 CARTON (63824-023-48) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-023-56 4 BLISTER PACK in 1 CARTON (63824-023-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Mucinex Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32471226-a16f-5531-e063-6394a90a382f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0363824023144"], "unii": ["495W7451VQ"], "rxcui": ["310621", "891297"], "spl_set_id": ["47f5323c-ee3a-400d-b133-31d9c286fafd"], "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 POUCH in 1 CARTON (63824-023-02)  / 1 TABLET, EXTENDED RELEASE in 1 POUCH", "package_ndc": "63824-023-02", "marketing_start_date": "20210701"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63824-023-07)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-023-07", "marketing_start_date": "20150611"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63824-023-35)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-023-35", "marketing_start_date": "20120626"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (63824-023-36)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-023-36", "marketing_start_date": "20120626"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (63824-023-46)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-023-46", "marketing_start_date": "20120626"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63824-023-48)  / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-023-48", "marketing_start_date": "20120626"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63824-023-56)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-023-56", "marketing_start_date": "20210701"}], "brand_name": "Mucinex Maximum Strength", "product_id": "63824-023_32471226-a16f-5531-e063-6394a90a382f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "63824-023", "generic_name": "Guaifenesin", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucinex", "brand_name_suffix": "Maximum Strength", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "NDA021282", "marketing_category": "NDA", "marketing_start_date": "20120626", "listing_expiration_date": "20261231"}