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United States · US · US:0573-0148_7ff3116f-dc72-460c-ac1a-80753f1aeb55

ADVIL PM

Orange BookUNIISPLATC D04AA

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

Identification

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

Packs · 2

  • ndc11
    0573014806
    1 BOTTLE in 1 CARTON (0573-0148-06) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    0573014807
    1 BOTTLE in 1 CARTON (0573-0148-07) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
N021393
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": {
    "a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7": {
      "match": "brand_token",
      "title": "ADVIL PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]",
      "spl_version": "3",
      "published_date": "2026-04-09"
    }
  },
  "productid": "0573-0148_7ff3116f-dc72-460c-ac1a-80753f1aeb55",
  "productndc": "0573-0148",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "021393",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG;EQ 200MG FREE ACID AND POTASSIUM SALT",
        "product_no": "001",
        "approval_date": "Dec 21, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN",
  "proprietary_name": "ADVIL PM",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021393",
  "marketing_category": "NDA",
  "nonproprietary_name": "diphenhydramine HCl, ibuprofen",
  "start_marketing_date": "20250115",
  "active_numerator_strength": "25; 200"
}

Related drugs

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