safetussin max strength ms cough, cold and flu

Generic: acetaminophen, dextromethorphan hydrobromide, and guaifenesin

Labeler: kramer laboratories
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name safetussin max strength ms cough, cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide, and guaifenesin
Labeler kramer laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1

Manufacturer
KRAMER LABORATORIES

Identifiers & Regulatory

Product NDC 55505-230
Product ID 55505-230_3dbd264d-5108-4b29-8881-728cea879dd7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-05-17

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 55505230
Hyphenated Format 55505-230

Supplemental Identifiers

RxCUI
2684921
UPC
0053076000085
UNII
362O9ITL9D 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 safetussin max strength ms cough, cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 24 TABLET in 1 CARTON (55505-230-24)
source: ndc

Packages (1)

55505-230-24 24 TABLET in 1 CARTON (55505-230-24)

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1)

Linked Drug Pages (1)

SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3dbd264d-5108-4b29-8881-728cea879dd7", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0053076000085"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ"], "rxcui": ["2684921"], "spl_set_id": ["920bde5f-4079-45de-aa59-24b00e50cb56"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["KRAMER LABORATORIES"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 TABLET in 1 CARTON (55505-230-24)", "package_ndc": "55505-230-24", "marketing_start_date": "20240517"}], "brand_name": "SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu", "product_id": "55505-230_3dbd264d-5108-4b29-8881-728cea879dd7", "dosage_form": "TABLET", "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": "55505-230", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin", "labeler_name": "KRAMER LABORATORIES", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SAFETUSSIN MAX STRENGTH MS", "brand_name_suffix": "Cough, Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240517", "listing_expiration_date": "20261231"}