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United States · US · US:41520-050_af71245d-9e26-4aaf-b061-3b2dc519572c

Care One Ibuprofen PM

Orange BookUNIISPLATC D04AA

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

Identification

ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeD04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4152005027
    1 BOTTLE in 1 CARTON (41520-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    4152005058
    1 BOTTLE in 1 CARTON (41520-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    4152005060
    1 BOTTLE in 1 CARTON (41520-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A079113
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4OD433S209",
    "rxcui": "82004",
    "inchikey": "SPCKHVPPRJWQRZ-UHFFFAOYSA-N",
    "display_name": "DIPHENHYDRAMINE CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "25b33a18-0b14-5411-e063-6294a90a31ee": {
      "match": "brand_token",
      "title": "CARE ONE CRISP CLEAN (BENZALKONIUM CHLORIDE) LIQUID [RETAIL BUSINESS SERVICES , LLC]",
      "spl_version": "5",
      "published_date": "2026-05-11"
    }
  },
  "productid": "41520-050_af71245d-9e26-4aaf-b061-3b2dc519572c",
  "productndc": "41520-050",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "079113",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "38MG;200MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
  "proprietary_name": "Care One Ibuprofen PM",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA079113",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diphenhydramine citrate and ibuprofen",
  "start_marketing_date": "20090220",
  "active_numerator_strength": "38; 200"
}

Related drugs

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