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United States · US · US:68196-102_1ba5f59e-81b7-c660-e063-6394a90af7fd

SIMPLY RIGHT

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerSam's West Inc
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6819610202
    2 BOTTLE in 1 CARTON (68196-102-02) / 120 mL in 1 BOTTLE
  • ndc11
    6819610207
    2 BOTTLE in 1 CARTON (68196-102-07) / 240 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A090182
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": {
    "6db037d4-c781-4cee-a4d5-52a93eccd55f": {
      "match": "brand_token",
      "title": "SIMPLY CLEAN DANDRUFF (PYRITHIONE ZINC) SHAMPOO [ALDI, INC]",
      "spl_version": "9",
      "published_date": "2026-05-14"
    }
  },
  "productid": "68196-102_1ba5f59e-81b7-c660-e063-6394a90af7fd",
  "productndc": "68196-102",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "090182",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Apr 22, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "002",
        "approval_date": "Apr 22, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "SIMPLY RIGHT",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA090182",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20110908",
  "active_numerator_strength": "5"
}

Related drugs

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