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United States · US · US:21130-644_e96874ea-3391-4837-a50e-4546a72e9278

signature care allergy relief d

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerSafeway
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2113064462
    24 BLISTER PACK in 1 CARTON (21130-644-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A210719
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "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": "21130-644_e96874ea-3391-4837-a50e-4546a72e9278",
  "productndc": "21130-644",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210719",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG;120MG",
        "product_no": "001",
        "approval_date": "Nov 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "signature care allergy relief d",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA210719",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cetirizine hydrochloride, pseudoephedrine hydrochloride",
  "start_marketing_date": "20210216",
  "active_numerator_strength": "5; 120"
}

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