ACTINEL PEDIATRIC

UNIISPLATC R05DA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerACTIPHARMA, LLC

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6310210216
474 mL in 1 BOTTLE (63102-102-16)

Annotations

UNII (FDA Substance ID)

9D2RTI9KYH

DEXTROMETHORPHAN HYDROBROMIDE

RxCUI 102490

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9D2RTI9KYH",
    "rxcui": "102490",
    "inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
    "display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f85d8586-423f-48a3-9bb2-bbc5984c7cd3": {
      "match": "brand_token",
      "title": "ACTINEL DM PEDIATRIC (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ACTIPHARMA, LLC]",
      "spl_version": "1",
      "published_date": "2026-02-13"
    }
  },
  "productid": "63102-102_eb2ae74b-0abd-4451-a6a3-f2c5b0fbcfbf",
  "productndc": "63102-102",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "ACTINEL PEDIATRIC",
  "active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl",
  "start_marketing_date": "20140924",
  "active_numerator_strength": "5; 50; 15"
}

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