actinel dm

Generic: dextromethorphan hbr, guaifenesin, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name actinel dm
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler actipharma, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/5mL, guaifenesin 400 mg/5mL, phenylephrine hydrochloride 10 mg/5mL

Manufacturer
ACTIPHARMA, LLC

Identifiers & Regulatory

Product NDC 63102-104
Product ID 63102-104_a0ce93a6-b45b-4f6f-a9b6-4be407871774
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-05-20

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 63102104
Hyphenated Format 63102-104

Supplemental Identifiers

RxCUI
1091331
UNII
9D2RTI9KYH 495W7451VQ 04JA59TNSJ
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 actinel dm (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
  • 400 mg/5mL
  • 10 mg/5mL
source: ndc
Packaging
  • 474 mL in 1 BOTTLE, PLASTIC (63102-104-16)
source: ndc

Packages (1)

63102-104-16 474 mL in 1 BOTTLE, PLASTIC (63102-104-16)

Ingredients (3)

dextromethorphan hydrobromide (20 mg/5mL) guaifenesin (400 mg/5mL) phenylephrine hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

ACTINEL DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a0ce93a6-b45b-4f6f-a9b6-4be407871774", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1091331"], "spl_set_id": ["16660d82-524b-42ca-8581-48237caa13b2"], "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": "474 mL in 1 BOTTLE, PLASTIC (63102-104-16)", "package_ndc": "63102-104-16", "marketing_start_date": "20190520"}], "brand_name": "ACTINEL DM", "product_id": "63102-104_a0ce93a6-b45b-4f6f-a9b6-4be407871774", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-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-1 Adrenergic Agonist [EPC]"], "product_ndc": "63102-104", "generic_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "ACTIPHARMA, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ACTINEL DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190520", "listing_expiration_date": "20261231"}