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United States · US · US:41520-429_88627121-1a2f-4818-a6d1-d1b06a92925e

CareOne Nasal and Sinus Decongestant

Orange BookUNIISPLATC R01BA52

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

Identification

ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeR01BA52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4152042952
    10 BLISTER PACK in 1 CARTON (41520-429-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    4152042960
    20 BLISTER PACK in 1 CARTON (41520-429-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A075153
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6V9V2RYJ8N",
    "rxcui": "91168",
    "inchikey": "BALXUFOVQVENIU-KXNXZCPBSA-N",
    "display_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "206f5483-7de1-4bc3-af27-190e211bcb95": {
      "match": "brand_token",
      "title": "CAREONE ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [AMERICAN SALES COMPANY]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "41520-429_88627121-1a2f-4818-a6d1-d1b06a92925e",
  "productndc": "41520-429",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "075153",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Feb 26, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "CareOne Nasal and Sinus Decongestant",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075153",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pseudoephedrine HCl",
  "start_marketing_date": "20160915",
  "active_numerator_strength": "120"
}

Related drugs

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