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United States · US · US:21130-814_463f13c5-0aeb-3fa5-e063-6394a90afe8c

Naproxen Sodium Diphenhydramine Hydrochloride

Orange BookUNIISPLATC D04AA

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

Identification

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

Packs · 1

  • ndc11
    2113081405
    50 TABLET in 1 BOTTLE (21130-814-05)

Annotations

UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A213663
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": {
    "c5146d73-2f34-4dfe-ac29-97071279dc4d": {
      "match": "brand_token",
      "title": "NAPROXEN SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "10",
      "published_date": "2026-05-28"
    }
  },
  "productid": "21130-814_463f13c5-0aeb-3fa5-e063-6394a90afe8c",
  "productndc": "21130-814",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213663",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG;220MG",
        "product_no": "001",
        "approval_date": "Sep 24, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM",
  "proprietary_name": "Naproxen Sodium Diphenhydramine Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA213663",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium Diphenhydramine Hydrochloride",
  "start_marketing_date": "20230630",
  "active_numerator_strength": "25; 220"
}

Related drugs

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