Acetaminophen and Ibuprofen Back Pain

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC codeN02BE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 29

ndc11
5860289501
1 BOTTLE, PLASTIC in 1 CARTON (58602-895-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289503
1 BOTTLE in 1 CARTON (58602-895-03) / 10 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289507
1 BOTTLE in 1 CARTON (58602-895-07) / 24 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289511
1 BOTTLE in 1 CARTON (58602-895-11) / 36 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289514
1 BOTTLE in 1 CARTON (58602-895-14) / 50 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289521
1 BOTTLE in 1 CARTON (58602-895-21) / 100 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289529
1 BOTTLE in 1 CARTON (58602-895-29) / 150 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289535
225 TABLET, FILM COATED in 1 BOTTLE (58602-895-35)
ndc11
5860289540
500 TABLET, FILM COATED in 1 BOTTLE (58602-895-40)
ndc11
5860289541
1000 TABLET, FILM COATED in 1 BOTTLE (58602-895-41)
ndc11
5860289544
400 TABLET, FILM COATED in 1 BOTTLE (58602-895-44)
ndc11
5860289546
1 BOTTLE, PLASTIC in 1 CARTON (58602-895-46) / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289549
1 BOTTLE, PLASTIC in 1 CARTON (58602-895-49) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289551
216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-51)
ndc11
5860289561
1 BLISTER PACK in 1 CARTON (58602-895-61) / 2 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5860289562
216 TABLET, FILM COATED in 1 BOTTLE (58602-895-62)
ndc11
5860289565
1 BOTTLE in 1 CARTON (58602-895-65) / 72 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289573
1 BOTTLE in 1 CARTON (58602-895-73) / 20 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289578
1 BOTTLE, PLASTIC in 1 CARTON (58602-895-78) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289579
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-79)
ndc11
5860289580
1 BOTTLE, PLASTIC in 1 CARTON (58602-895-80) / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289582
1 BOTTLE in 1 CARTON (58602-895-82) / 18 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860289584
225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-84)
ndc11
5860289585
1 BOTTLE, PLASTIC in 1 CARTON (58602-895-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289588
750 TABLET, FILM COATED in 1 BOTTLE (58602-895-88)
ndc11
5860289594
1 BOTTLE, PLASTIC in 1 CARTON (58602-895-94) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289595
750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-95)
ndc11
5860289596
1 BOTTLE, PLASTIC in 1 CARTON (58602-895-96) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5860289599
400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-99)

Annotations

UNII (FDA Substance ID)

362O9ITL9D

ACETAMINOPHEN

RxCUI 161

Orange Book

A218359

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Acetaminophen; Oxycodone Hydrochloride Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "44520aa1-b63f-4239-e063-6394a90a5e14": {
      "match": "brand_token",
      "title": "ACETAMINOPHEN LIQUID / ACETAMINOPHEN DIPHENHYDRAMINE HCL LIQUID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [KROGER]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "58602-895_358fae0b-3a56-4ffa-ba09-de83cd8200a5",
  "productndc": "58602-895",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218359",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;125MG",
        "product_no": "001",
        "approval_date": "Mar 26, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; IBUPROFEN",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Acetaminophen and Ibuprofen Back Pain",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA218359",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen and Ibuprofen",
  "start_marketing_date": "20240326",
  "active_numerator_strength": "250; 125"
}

Related drugs

Other records sharing ATC code N02BE.

Access this data programmatically

Query Acetaminophen and Ibuprofen Back Pain and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs