Back to search
🇺🇸

United States · US · US:58602-887_2c7c5349-06c9-401a-88e9-8f91ddb7f91a

Diphenhydramine HCl and Ibuprofen

Orange BookUNIISPLATC D04AA

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

Identification

ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeD04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    5860288710
    1 BOTTLE in 1 CARTON (58602-887-10) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    5860288712
    1 BOTTLE in 1 CARTON (58602-887-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    5860288718
    1 BOTTLE in 1 CARTON (58602-887-18) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    5860288723
    120 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-887-23)
  • ndc11
    5860288730
    160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-887-30)
  • ndc11
    5860288773
    1 BOTTLE in 1 CARTON (58602-887-73) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A210676
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": {
    "48ede5ab-207b-cf0c-e063-6394a90a419f": {
      "match": "brand_token",
      "title": "DIPHENHYDRAMINE ORAL SOLUTION (DIPHENHYDRAMINE HCL12.5MG/5ML) SOLUTION [ALDAMA PHARMACEUTICALS, INC]",
      "spl_version": "3",
      "published_date": "2026-06-02"
    }
  },
  "productid": "58602-887_2c7c5349-06c9-401a-88e9-8f91ddb7f91a",
  "productndc": "58602-887",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "210676",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG;EQ 200MG FREE ACID AND POTASSIUM SALT",
        "product_no": "001",
        "approval_date": "Feb 14, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN",
  "proprietary_name": "Diphenhydramine HCl and Ibuprofen",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA210676",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diphenhydramine HCl and Ibuprofen",
  "start_marketing_date": "20220810",
  "active_numerator_strength": "25; 200"
}

Related drugs

Other records sharing ATC code D04AA.

Access this data programmatically

Query Diphenhydramine HCl and Ibuprofen and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.