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United States · US · US:21130-440_9d47bcef-ac34-445c-9e4d-3c091e5715a8

signature care anti diarrheal

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerSafeway
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2113044034
    1 BOTTLE in 1 CARTON (21130-440-34) / 240 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A091292
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "77TI35393C",
    "rxcui": "82038",
    "inchikey": "PGYPOBZJRVSMDS-UHFFFAOYSA-N",
    "display_name": "LOPERAMIDE 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": "21130-440_9d47bcef-ac34-445c-9e4d-3c091e5715a8",
  "productndc": "21130-440",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "091292",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG/7.5ML",
        "product_no": "001",
        "approval_date": "May 20, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "signature care anti diarrheal",
  "active_ingred_unit": "mg/7.5mL",
  "application_number": "ANDA091292",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loperamide HCl",
  "start_marketing_date": "20180712",
  "active_numerator_strength": "1"
}

Related drugs

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