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United States · US · US:36800-612_9fd9c4c8-9520-470a-9deb-e050233a6e92

TopCare Allergy Relief

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    3680061203
    1 BOTTLE in 1 CARTON (36800-612-03) / 70 TABLET in 1 BOTTLE
  • ndc11
    3680061246
    10 BLISTER PACK in 1 CARTON (36800-612-46) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    3680061258
    1 BOTTLE in 1 CARTON (36800-612-58) / 40 TABLET in 1 BOTTLE
  • ndc11
    3680061265
    1 BOTTLE in 1 CARTON (36800-612-65) / 30 TABLET in 1 BOTTLE
  • ndc11
    3680061287
    1 BOTTLE in 1 CARTON (36800-612-87) / 300 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076301
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7AJO3BO7QN",
    "rxcui": "28889",
    "inchikey": "JCCNYMKQOSZNPW-UHFFFAOYSA-N",
    "display_name": "LORATADINE",
    "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": "36800-612_9fd9c4c8-9520-470a-9deb-e050233a6e92",
  "productndc": "36800-612",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076301",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 25, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "TopCare Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076301",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20050125",
  "active_numerator_strength": "10"
}

Related drugs

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