mucus extended release

Generic: guaifenesin

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucus extended release
Generic Name guaifenesin
Labeler cvs woonsocket prescription center, incorporated
Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 1200 mg/1

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-400
Product ID 51316-400_26d906cf-86ee-4c11-92e6-491b5ea405e7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078912
Listing Expiration 2026-12-31
Marketing Start 2025-06-17

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 51316400
Hyphenated Format 51316-400

Supplemental Identifiers

RxCUI
310621
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 extended release (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA078912 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/1
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (51316-400-55) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (51316-400-74) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

51316-400-55 6 BLISTER PACK in 1 CARTON (51316-400-55) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK 51316-400-74 2 BLISTER PACK in 1 CARTON (51316-400-74) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (1200 mg/1)

Linked Drug Pages (1)

mucus extended release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26d906cf-86ee-4c11-92e6-491b5ea405e7", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["9fcf96a7-bef4-4cc8-bd9e-c245ccbea17d"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (51316-400-55)  / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-400-55", "marketing_start_date": "20250617"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51316-400-74)  / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-400-74", "marketing_start_date": "20250617"}], "brand_name": "mucus extended release", "product_id": "51316-400_26d906cf-86ee-4c11-92e6-491b5ea405e7", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "51316-400", "generic_name": "guaifenesin", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "mucus extended release", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA078912", "marketing_category": "ANDA", "marketing_start_date": "20250617", "listing_expiration_date": "20261231"}