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United States · US · US:69452-205_0f6b5911-edb2-4e3a-b121-45c609b4c60e

IBUPROFEN, DIPHENHYDRAMINE HCL

Orange BookUNIISPLATC D04AA

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

Identification

ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeD04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6945220504
    1 BLISTER PACK in 1 CARTON (69452-205-04) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • ndc11
    6945220511
    20 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-11)
  • ndc11
    6945220515
    40 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-15)
  • ndc11
    6945220520
    100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-20)
  • ndc11
    6945220578
    80 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-78)

Annotations

UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A090397
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TC2D6JAD40",
    "rxcui": "1362",
    "inchikey": "PCHPORCSPXIHLZ-UHFFFAOYSA-N",
    "display_name": "DIPHENHYDRAMINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "97e2c008-1711-dcba-e053-2995a90aa2ff": {
      "match": "brand_token",
      "title": "IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [TARGET CORPORATION]",
      "spl_version": "3",
      "published_date": "2025-12-18"
    }
  },
  "productid": "69452-205_0f6b5911-edb2-4e3a-b121-45c609b4c60e",
  "productndc": "69452-205",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "090397",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG;EQ 200MG FREE ACID AND POTASSIUM SALT",
        "product_no": "001",
        "approval_date": "Nov 22, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN",
  "proprietary_name": "IBUPROFEN, DIPHENHYDRAMINE HCL",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA090397",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IBUPROFEN, DIPHENHYDRAMINE HCL",
  "start_marketing_date": "20181101",
  "active_numerator_strength": "25; 200"
}

Related drugs

Other records sharing ATC code D04AA.

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