equate allergy relief

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerWal-Mart Stores Inc

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
4903545848
2 BOTTLE in 1 CARTON (49035-458-48) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
4903545866
14 BLISTER PACK in 1 CARTON (49035-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
4903545875
1 BOTTLE in 1 CARTON (49035-458-75) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
4903545887
1 BOTTLE in 1 CARTON (49035-458-87) / 300 TABLET, FILM COATED in 1 BOTTLE
ndc11
4903545895
1 BOTTLE in 1 CARTON (49035-458-95) / 45 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A078336

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": {
    "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": "49035-458_8478b5cf-8c1f-40f6-9d98-ffdce498cbe1",
  "productndc": "49035-458",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078336",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Dec 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Dec 27, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "equate allergy relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078336",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20080109",
  "active_numerator_strength": "10"
}

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