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United States · US · US:36800-490_07c1ea6c-a75e-4600-b44b-4e1562fde80b

Topcare All Day Pain Relief

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3680049062
    1 BOTTLE in 1 CARTON (36800-490-62) / 24 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    3680049071
    1 BOTTLE in 1 CARTON (36800-490-71) / 50 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    3680049075
    1 BOTTLE in 1 CARTON (36800-490-75) / 90 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A074661
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9TN87S3A3C",
    "rxcui": "142442",
    "inchikey": "CDBRNDSHEYLDJV-FVGYRXGTSA-M",
    "display_name": "NAPROXEN SODIUM",
    "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": "36800-490_07c1ea6c-a75e-4600-b44b-4e1562fde80b",
  "productndc": "36800-490",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "074661",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "220MG",
        "product_no": "001",
        "approval_date": "Jan 13, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "Topcare All Day Pain Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074661",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "19970114",
  "active_numerator_strength": "220"
}

Related drugs

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