safetussin high blood pressure and diabetes 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 high blood pressure and diabetes cough, cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide, and guaifenesin
Labeler kramer laboratories
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, guaifenesin 400 mg/30mL

Manufacturer
KRAMER LABORATORIES

Identifiers & Regulatory

Product NDC 55505-217
Product ID 55505-217_df0f0e0c-323c-49e5-8432-c09cf950b20d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-04-17

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 55505217
Hyphenated Format 55505-217

Supplemental Identifiers

RxCUI
1042695
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 high blood pressure and diabetes 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
  • 650 mg/30mL
  • 20 mg/30mL
  • 400 mg/30mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE, PLASTIC (55505-217-36)
source: ndc

Packages (1)

55505-217-36 237 mL in 1 BOTTLE, PLASTIC (55505-217-36)

Ingredients (3)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) guaifenesin (400 mg/30mL)

Linked Drug Pages (1)

Safetussin High Blood Pressure and diabetes Cough, Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "df0f0e0c-323c-49e5-8432-c09cf950b20d", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1042695"], "spl_set_id": ["279e309c-040d-4001-808d-b7d986a9a1d8"], "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": "237 mL in 1 BOTTLE, PLASTIC (55505-217-36)", "package_ndc": "55505-217-36", "marketing_start_date": "20230417"}], "brand_name": "Safetussin High Blood Pressure and diabetes Cough, Cold and Flu", "product_id": "55505-217_df0f0e0c-323c-49e5-8432-c09cf950b20d", "dosage_form": "LIQUID", "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": "55505-217", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin", "labeler_name": "KRAMER LABORATORIES", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Safetussin High Blood Pressure and diabetes", "brand_name_suffix": "Cough, Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230417", "listing_expiration_date": "20261231"}