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United States · US · US:0113-0847_5cd21fe5-5a25-4beb-a480-924996e65ee1

good sense aller ease

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerL. Perrigo Company
CountryUS (United States)
ATC codeR06AX26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    0113084722
    15 BLISTER PACK in 1 CARTON (0113-0847-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0113084739
    1 BOTTLE in 1 CARTON (0113-0847-39) / 30 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0113084747
    1 BOTTLE in 1 CARTON (0113-0847-47) / 150 TABLET, FILM COATED in 1 BOTTLE (0113-0847-00)
  • ndc11
    0113084795
    1 BOTTLE in 1 CARTON (0113-0847-95) / 45 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A212971
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2S068B75ZU",
    "rxcui": "236474",
    "inchikey": "RRJFVPUCXDGFJB-UHFFFAOYSA-N",
    "display_name": "FEXOFENADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d503b10f-85cd-4bb8-9dec-82d651d525fa": {
      "match": "brand_token",
      "title": "GOOD NEIGHBOR PHARMACY EARWAX REMOVAL (CARBAMIDE PEROXIDE) KIT [AMERISOURCE BERGEN]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0113-0847_5cd21fe5-5a25-4beb-a480-924996e65ee1",
  "productndc": "0113-0847",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212971",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Feb 24, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Feb 24, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "good sense aller ease",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212971",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fexofenadine hydrochloride",
  "start_marketing_date": "20210910",
  "active_numerator_strength": "180"
}

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