Ibuprofen and Diphenhydramine Citrate

Orange BookUNIISPLATC D04AA

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

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC codeD04AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 17

ndc11
5860286709
1 BOTTLE in 1 CARTON (58602-867-09) / 30 TABLET, COATED in 1 BOTTLE
ndc11
5860286712
1 BOTTLE in 1 CARTON (58602-867-12) / 40 TABLET, COATED in 1 BOTTLE
ndc11
5860286714
1 BOTTLE in 1 CARTON (58602-867-14) / 50 TABLET, COATED in 1 BOTTLE
ndc11
5860286718
1 BOTTLE in 1 CARTON (58602-867-18) / 80 TABLET, COATED in 1 BOTTLE
ndc11
5860286721
1 BOTTLE in 1 CARTON (58602-867-21) / 100 TABLET, COATED in 1 BOTTLE
ndc11
5860286723
1 BOTTLE in 1 CARTON (58602-867-23) / 120 TABLET, COATED in 1 BOTTLE
ndc11
5860286727
140 TABLET, COATED in 1 BOTTLE (58602-867-27)
ndc11
5860286732
180 TABLET, COATED in 1 BOTTLE (58602-867-32)
ndc11
5860286734
200 TABLET, COATED in 1 BOTTLE (58602-867-34)
ndc11
5860286746
140 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-46)
ndc11
5860286770
1 BOTTLE, PLASTIC in 1 CARTON (58602-867-70) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC
ndc11
5860286772
1 BOTTLE, PLASTIC in 1 CARTON (58602-867-72) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC
ndc11
5860286773
1 BOTTLE in 1 CARTON (58602-867-73) / 20 TABLET, COATED in 1 BOTTLE
ndc11
5860286778
1 BOTTLE, PLASTIC in 1 CARTON (58602-867-78) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
ndc11
5860286780
200 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-80)
ndc11
5860286792
180 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-92)
ndc11
5860286797
120 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-97)

Annotations

UNII (FDA Substance ID)

4OD433S209

DIPHENHYDRAMINE CITRATE

RxCUI 82004

Orange Book

A216204

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": {
    "aeee629b-255c-40d8-8e95-779aec00f723": {
      "match": "brand_token",
      "title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "58602-867_21c1f5c5-19fa-4a59-bad3-ea85fd37471b",
  "productndc": "58602-867",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "216204",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "38MG;200MG",
        "product_no": "001",
        "approval_date": "May 31, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
  "proprietary_name": "Ibuprofen and Diphenhydramine Citrate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA216204",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen and Diphenhydramine Citrate",
  "start_marketing_date": "20220531",
  "active_numerator_strength": "38; 200"
}

Related drugs

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