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United States · US · US:37808-264_7f8e2c7c-648d-488d-bd75-b9f353ce0424

naproxen sodium pm

Orange BookUNIISPLATC D04AA

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

Identification

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

Packs · 2

  • ndc11
    3780826427
    1 BOTTLE in 1 CARTON (37808-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    3780826460
    1 BOTTLE in 1 CARTON (37808-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A208499
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": "37808-264_7f8e2c7c-648d-488d-bd75-b9f353ce0424",
  "productndc": "37808-264",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208499",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG;220MG",
        "product_no": "001",
        "approval_date": "May 10, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM",
  "proprietary_name": "naproxen sodium pm",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA208499",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diphenhydramine hydrochloride, naproxen sodium",
  "start_marketing_date": "20201013",
  "active_numerator_strength": "25; 220"
}

Related drugs

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