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United States · US · US:21130-890_11838dd7-aea8-45f5-a25a-374b2e8858f6

signature care childrens 12 hour cough relief

Orange BookUNIISPLATC N07XX59

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

Identification

ManufacturerSafeway
CountryUS (United States)
ATC codeN07XX59
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2113089021
    1 BOTTLE in 1 CARTON (21130-890-21) / 89 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": {
    "4f555b8f-5193-e685-e063-6294a90a7ba2": {
      "match": "brand_token",
      "title": "SIGNATURE PAIN RELIEF CREAM (4% LIDOCAINE) CREAM [SHENGNAN (GUANGZHOU) COSMETICS CO., LTD]",
      "spl_version": "1",
      "published_date": "2026-04-14"
    }
  },
  "productid": "21130-890_11838dd7-aea8-45f5-a25a-374b2e8858f6",
  "productndc": "21130-890",
  "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": "signature care childrens 12 hour cough relief",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA091135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dextromethorphan polistirex",
  "start_marketing_date": "20220527",
  "active_numerator_strength": "30"
}

Related drugs

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