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United States · US · US:0280-1200_45265ccc-d985-a6ad-e063-6394a90a75b7

Aleve PM

Orange BookUNIISPLATC D04AA

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

Identification

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

Packs · 9

  • ndc11
    0280120005
    80 TABLET, FILM COATED in 1 BOTTLE (0280-1200-05)
  • ndc11
    0280120001
    1 BOTTLE in 1 CARTON (0280-1200-01) / 120 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0280120002
    2 TABLET, FILM COATED in 1 POUCH (0280-1200-02)
  • ndc11
    0280120003
    160 TABLET, FILM COATED in 1 BOTTLE (0280-1200-03)
  • ndc11
    0280120004
    1 BOTTLE in 1 CARTON (0280-1200-04) / 40 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0280120008
    1 BOTTLE in 1 CARTON (0280-1200-08) / 250 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0280120020
    1 BOTTLE in 1 CARTON (0280-1200-20) / 20 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0280120040
    1 BOTTLE in 1 CARTON (0280-1200-40) / 40 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0280120080
    1 BOTTLE in 1 CARTON (0280-1200-80) / 80 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
N205352
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": {
    "590f3be2-20df-4643-9114-e7ed4cf9155c": {
      "match": "brand_token",
      "title": "ALEVE (NAPROXEN SODIUM) TABLET [NAVAJO MANUFACTURING COMPANY INC.]",
      "spl_version": "5",
      "published_date": "2026-04-09"
    }
  },
  "productid": "0280-1200_45265ccc-d985-a6ad-e063-6394a90a75b7",
  "productndc": "0280-1200",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205352",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG;220MG",
        "product_no": "001",
        "approval_date": "Jan 17, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM",
  "proprietary_name": "Aleve PM",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA205352",
  "marketing_category": "NDA",
  "nonproprietary_name": "DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM",
  "start_marketing_date": "20140909",
  "active_numerator_strength": "25; 220"
}

Related drugs

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