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United States · US · US:42961-103_0a04be19-a326-4471-b3bb-40ba993caf50

First Aid Direct Anti-Diarrheal

Orange BookUNIISPLATC A07DA03

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

Identification

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

Packs · 1

  • ndc11
    4296110302
    2 BLISTER PACK in 1 BOX (42961-103-02) / 6 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A076497
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": {
    "5258cef2-0e5c-4ccd-e063-6394a90a9e5c": {
      "match": "brand_token",
      "title": "FIRST AID ONLY LIDOCAINE HYDROCHLORIDE ANALGESIC BURN GEL (LIDOCAINE HYDROCHLORIDE) GEL [ACME UNITED CORPORATION]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "42961-103_0a04be19-a326-4471-b3bb-40ba993caf50",
  "productndc": "42961-103",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076497",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jun 10, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "First Aid Direct Anti-Diarrheal",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076497",
  "marketing_category": "ANDA",
  "nonproprietary_name": "First Aid Direct Anti-Diarrheal",
  "start_marketing_date": "20211020",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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