giltuss ex maximum strength expectorant

Generic: giltuss ex maximum strength expectorant

Labeler: gil pharmaceutical corp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name giltuss ex maximum strength expectorant
Generic Name giltuss ex maximum strength expectorant
Labeler gil pharmaceutical corp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 1200 mg/1

Manufacturer
Gil Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 58552-341
Product ID 58552-341_40bac4fd-b941-9b31-e063-6294a90ae6ba
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-10-07

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 58552341
Hyphenated Format 58552-341

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 giltuss ex maximum strength expectorant (source: ndc)
Generic Name giltuss ex maximum strength expectorant (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (58552-341-07) / 7 TABLET in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (58552-341-20) / 14 TABLET in 1 BOTTLE
source: ndc

Packages (2)

58552-341-07 1 BLISTER PACK in 1 CARTON (58552-341-07) / 7 TABLET in 1 BLISTER PACK 58552-341-20 1 BOTTLE in 1 CARTON (58552-341-20) / 14 TABLET in 1 BOTTLE

Ingredients (1)

guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Giltuss EX Maximum Strength Expectorant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40bac4fd-b941-9b31-e063-6294a90ae6ba", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["950db1ca-6936-47f8-a112-e3594d4c922c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Gil Pharmaceutical Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BLISTER PACK in 1 CARTON (58552-341-07)  / 7 TABLET in 1 BLISTER PACK", "package_ndc": "58552-341-07", "marketing_start_date": "20251007"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58552-341-20)  / 14 TABLET in 1 BOTTLE", "package_ndc": "58552-341-20", "marketing_start_date": "20251007"}], "brand_name": "Giltuss EX Maximum Strength Expectorant", "product_id": "58552-341_40bac4fd-b941-9b31-e063-6294a90ae6ba", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "58552-341", "generic_name": "Giltuss EX Maximum Strength Expectorant", "labeler_name": "Gil Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss EX Maximum Strength Expectorant", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251007", "listing_expiration_date": "20261231"}