actispec pse

Generic: dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride

Labeler: actipharma, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name actispec pse
Generic Name dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride
Labeler actipharma, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 187 mg/5mL, pseudoephedrine hydrochloride 30 mg/5mL

Manufacturer
ACTIPHARMA, LLC

Identifiers & Regulatory

Product NDC 63102-120
Product ID 63102-120_109b340a-cf73-4886-87d5-edf2702f6a2c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-07-17

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 63102120
Hyphenated Format 63102-120

Supplemental Identifiers

RxCUI
1435143
UNII
9D2RTI9KYH 495W7451VQ 6V9V2RYJ8N
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 actispec pse (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 187 mg/5mL
  • 30 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (63102-120-16)
source: ndc

Packages (1)

63102-120-16 473 mL in 1 BOTTLE (63102-120-16)

Ingredients (3)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (187 mg/5mL) pseudoephedrine hydrochloride (30 mg/5mL)

Linked Drug Pages (1)

ACTISPEC PSE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "109b340a-cf73-4886-87d5-edf2702f6a2c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1435143"], "spl_set_id": ["5def1555-87f4-41d5-8a5c-be560aa8f1e2"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["ACTIPHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (63102-120-16)", "package_ndc": "63102-120-16", "marketing_start_date": "20250717"}], "brand_name": "ACTISPEC PSE", "product_id": "63102-120_109b340a-cf73-4886-87d5-edf2702f6a2c", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "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]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "63102-120", "generic_name": "Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride", "labeler_name": "ACTIPHARMA, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ACTISPEC PSE", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "187 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250717", "listing_expiration_date": "20261231"}