childrens giltuss ex expectorant

Generic: guaifenesin

Labeler: dextrum laboratories inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens giltuss ex expectorant
Generic Name guaifenesin
Labeler dextrum laboratories inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

guaifenesin 200 mg/5mL

Manufacturer
Dextrum Laboratories Inc.

Identifiers & Regulatory

Product NDC 65852-016
Product ID 65852-016_3f8d7d47-f14d-888c-e063-6394a90a5cdd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-06-22

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 65852016
Hyphenated Format 65852-016

Supplemental Identifiers

RxCUI
310625
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 childrens giltuss ex expectorant (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (65852-016-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

65852-016-04 1 BOTTLE, PLASTIC in 1 CARTON (65852-016-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

guaifenesin (200 mg/5mL)

Linked Drug Pages (1)

Childrens Giltuss EX Expectorant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f8d7d47-f14d-888c-e063-6394a90a5cdd", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310625"], "spl_set_id": ["3f8d7d47-f14c-888c-e063-6394a90a5cdd"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Dextrum Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (65852-016-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65852-016-04", "marketing_start_date": "20200622"}], "brand_name": "Childrens Giltuss EX Expectorant", "product_id": "65852-016_3f8d7d47-f14d-888c-e063-6394a90a5cdd", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "65852-016", "generic_name": "Guaifenesin", "labeler_name": "Dextrum Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Giltuss EX Expectorant", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "200 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200622", "listing_expiration_date": "20261231"}