alka seltzer plus maximum strength cough chest congestion powerfast fizz

Generic: dextromethorphan hydrobromide, guaifenesin

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name alka seltzer plus maximum strength cough chest congestion powerfast fizz
Generic Name dextromethorphan hydrobromide, guaifenesin
Labeler bayer healthcare llc.
Dosage Form TABLET, EFFERVESCENT
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1

Manufacturer
Bayer Healthcare LLC.

Identifiers & Regulatory

Product NDC 0280-0089
Product ID 0280-0089_4526573a-7900-980c-e063-6394a90a5fbd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-04-05

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 02800089
Hyphenated Format 0280-0089

Supplemental Identifiers

RxCUI
2598125
UPC
0016500598923
UNII
9D2RTI9KYH 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 alka seltzer plus maximum strength cough chest congestion powerfast fizz (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 20 POUCH in 1 CARTON (0280-0089-01) / 2 TABLET, EFFERVESCENT in 1 POUCH
  • 12 POUCH in 1 CARTON (0280-0089-02) / 2 TABLET, EFFERVESCENT in 1 POUCH
source: ndc

Packages (2)

Ingredients (2)

dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4526573a-7900-980c-e063-6394a90a5fbd", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0016500598923"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["2598125"], "spl_set_id": ["a32e2a5e-9aa0-4e7c-e053-2995a90a3190"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Bayer Healthcare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 POUCH in 1 CARTON (0280-0089-01)  / 2 TABLET, EFFERVESCENT in 1 POUCH", "package_ndc": "0280-0089-01", "marketing_start_date": "20220405"}, {"sample": false, "description": "12 POUCH in 1 CARTON (0280-0089-02)  / 2 TABLET, EFFERVESCENT in 1 POUCH", "package_ndc": "0280-0089-02", "marketing_start_date": "20230308"}], "brand_name": "Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz", "product_id": "0280-0089_4526573a-7900-980c-e063-6394a90a5fbd", "dosage_form": "TABLET, EFFERVESCENT", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "0280-0089", "generic_name": "dextromethorphan hydrobromide, guaifenesin", "labeler_name": "Bayer Healthcare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220405", "listing_expiration_date": "20261231"}