topcare all day allergy

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerTopco Associates LLC

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
3680044809
1 BOTTLE in 1 PACKAGE (36800-448-09) / 65 CAPSULE, LIQUID FILLED in 1 BOTTLE
ndc11
3680044849
1 BOTTLE in 1 PACKAGE (36800-448-49) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
ndc11
3680044863
1 BOTTLE in 1 PACKAGE (36800-448-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A213105

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE 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": "36800-448_eb748140-aec8-4fcf-9597-20610d87635a",
  "productndc": "36800-448",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "213105",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Sep 21, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "topcare all day allergy",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213105",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cetirizine hydrochloride",
  "start_marketing_date": "20220228",
  "active_numerator_strength": "10"
}

Related drugs

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