actinel pediatric

Generic: dextromethorphan hbr,guaifenesin,pseudoephedrine hcl

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

Drug Facts

Product Profile

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

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 50 mg/5mL, pseudoephedrine hydrochloride 15 mg/5mL

Manufacturer
ACTIPHARMA, LLC

Identifiers & Regulatory

Product NDC 63102-102
Product ID 63102-102_eb2ae74b-0abd-4451-a6a3-f2c5b0fbcfbf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-09-24

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 63102102
Hyphenated Format 63102-102

Supplemental Identifiers

RxCUI
1098911
UPC
0663102102166
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 actinel pediatric (source: ndc)
Generic Name dextromethorphan hbr,guaifenesin,pseudoephedrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 50 mg/5mL
  • 15 mg/5mL
source: ndc
Packaging
  • 474 mL in 1 BOTTLE (63102-102-16)
source: ndc

Packages (1)

63102-102-16 474 mL in 1 BOTTLE (63102-102-16)

Ingredients (3)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (50 mg/5mL) pseudoephedrine hydrochloride (15 mg/5mL)

Linked Drug Pages (1)

ACTINEL PEDIATRIC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eb2ae74b-0abd-4451-a6a3-f2c5b0fbcfbf", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0663102102166"], "unii": ["9D2RTI9KYH", "495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1098911"], "spl_set_id": ["6bb92d74-4893-40b8-af58-eb307155e876"], "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 (63102-102-16)", "package_ndc": "63102-102-16", "marketing_start_date": "20140924"}], "brand_name": "ACTINEL PEDIATRIC", "product_id": "63102-102_eb2ae74b-0abd-4451-a6a3-f2c5b0fbcfbf", "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": "63102-102", "generic_name": "Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl", "labeler_name": "ACTIPHARMA, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ACTINEL PEDIATRIC", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "50 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "15 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140924", "listing_expiration_date": "20261231"}