ADVIL PM

Orange BookUNIISPLATC D04AA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHaleon US Holdings LLC

CountryUS (United States)

ATC codeD04AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 21

ndc11
0573016404
4 TABLET, COATED in 1 POUCH (0573-0164-04)
ndc11
0573016405
2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE
ndc11
0573016408
1 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIAL
ndc11
0573016409
8 TABLET, COATED in 1 VIAL (0573-0164-09)
ndc11
0573016412
6 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCH
ndc11
0573016414
2 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCH
ndc11
0573016420
1 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLE
ndc11
0573016421
1 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLE
ndc11
0573016430
1 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLE
ndc11
0573016432
1 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLE
ndc11
0573016433
1 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLE
ndc11
0573016440
1 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLE
ndc11
0573016441
1 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLE
ndc11
0573016443
1 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLE
ndc11
0573016444
1 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLE
ndc11
0573016445
1 BOTTLE in 1 CARTON (0573-0164-45) / 180 TABLET, COATED in 1 BOTTLE
ndc11
0573016446
1 BOTTLE in 1 CARTON (0573-0164-46) / 180 TABLET, COATED in 1 BOTTLE
ndc11
0573016449
1 BOTTLE in 1 CARTON (0573-0164-49) / 200 TABLET, COATED in 1 BOTTLE
ndc11
0573016455
50 POUCH in 1 TRAY (0573-0164-55) / 2 TABLET, COATED in 1 POUCH
ndc11
0573016465
120 TABLET, COATED in 1 BOTTLE (0573-0164-65)
ndc11
0573016491
3000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCH

Annotations

UNII (FDA Substance ID)

4OD433S209

DIPHENHYDRAMINE CITRATE

RxCUI 82004

Orange Book

N021394

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4OD433S209",
    "rxcui": "82004",
    "inchikey": "SPCKHVPPRJWQRZ-UHFFFAOYSA-N",
    "display_name": "DIPHENHYDRAMINE CITRATE",
    "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": "0573-0164_15971707-84cd-4742-e063-6394a90af906",
  "productndc": "0573-0164",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "021394",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "38MG;200MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
  "proprietary_name": "ADVIL PM",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021394",
  "marketing_category": "NDA",
  "nonproprietary_name": "diphenhydramine citrate and ibuprofen",
  "start_marketing_date": "20051221",
  "active_numerator_strength": "38; 200"
}

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