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United States · US · US:49035-643_7acb58ab-357f-413d-bb57-2dc33ef0f709

equate allergy and congestion relief

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerWal-Mart Stores Inc
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4903564346
    10 BLISTER PACK in 1 CARTON (49035-643-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    4903564360
    20 BLISTER PACK in 1 CARTON (49035-643-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076050
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": {
    "2ac53cc7-000f-41fd-b799-4e6d6886fe62": {
      "match": "brand_token",
      "title": "EQUATE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "49035-643_7acb58ab-357f-413d-bb57-2dc33ef0f709",
  "productndc": "49035-643",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076050",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG;120MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
  "proprietary_name": "equate allergy and congestion relief",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076050",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loratadine, pseudoephedrine sulfate",
  "start_marketing_date": "20200724",
  "active_numerator_strength": "5; 120"
}

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