Topcare All Day Allergy

Orange BookUNIISPLATC R06AE09

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

Identification

ManufacturerTopco Associates LLC

CountryUS (United States)

ATC codeR06AE09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
3680024101
1 BOTTLE in 1 CARTON (36800-241-01) / 35 TABLET, FILM COATED in 1 BOTTLE
ndc11
3680024146
10 BLISTER PACK in 1 CARTON (36800-241-46) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
3680024195
1 BOTTLE in 1 CARTON (36800-241-95) / 45 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

SOD6A38AGA

LEVOCETIRIZINE DIHYDROCHLORIDE

RxCUI 402349

Orange Book

A211983

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "SOD6A38AGA",
    "rxcui": "402349",
    "inchikey": "PGLIUCLTXOYQMV-GHVWMZMZSA-N",
    "display_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
    "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": "36800-241_e685d7d8-ba5f-424a-9a98-54bde72bfacf",
  "productndc": "36800-241",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211983",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
  "proprietary_name": "Topcare All Day Allergy",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211983",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levocetirizine dihydrochloride",
  "start_marketing_date": "20200205",
  "active_numerator_strength": "5"
}

Related drugs

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