topcare allergy relief

Orange BookUNIISPLATC R06AX26

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTopco Associates LLC

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
3680069139
1 BOTTLE in 1 CARTON (36800-691-39) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
3680069149
1 BOTTLE in 1 CARTON (36800-691-49) / 40 TABLET, FILM COATED in 1 BOTTLE
ndc11
3680069175
1 BOTTLE in 1 CARTON (36800-691-75) / 90 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": {
    "a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
      "match": "brand_token",
      "title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "36800-691_9cb64047-5e7e-4fbc-913a-e3831cf557f4",
  "productndc": "36800-691",
  "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": "topcare allergy relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212971",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fexofenadine hydrochloride",
  "start_marketing_date": "20210823",
  "active_numerator_strength": "180"
}

Related drugs

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