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United States · US · US:51316-429_eefe8520-21e9-48ad-9973-e1193459c1bc

CHILDRENS 12 HR COUGH RELIEF

Orange BookUNIISPLATC N07XX59

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
CountryUS (United States)
ATC codeN07XX59
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5131642928
    1 BOTTLE in 1 CARTON (51316-429-28) / 148 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A091135
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": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "51316-429_eefe8520-21e9-48ad-9973-e1193459c1bc",
  "productndc": "51316-429",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "091135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 30MG HYDROBROMIDE/5ML",
        "product_no": "001",
        "approval_date": "May 25, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE",
  "proprietary_name": "CHILDRENS 12 HR COUGH RELIEF",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA091135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dextromethorphan polistirex",
  "start_marketing_date": "20260317",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code N07XX59.

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