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United States· US:58602-895_358fae0b-3a56-4ffa-ba09-de83cd8200a5

Acetaminophen and Ibuprofen Back Pain

A medicinal product containing acetaminophen; ibuprofen, registered in United States by Aurohealth LLC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAcetaminophen and Ibuprofen Back PainATC—REGISTER NO.US:58602-895_358fae0b…PACKS LISTED50CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ACETAMINOPHEN; IBUPROFEN
Manufacturer
Aurohealth LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 50

  • ndc11
    58602-895-82
  • ndc11
    58602-895-84
  • 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)
  • ndc11
    58602-895-01
  • ndc11
    58602-895-03
  • ndc11
    58602-895-07
  • ndc11
    58602-895-11
  • ndc11
    58602-895-14
  • ndc11
    58602-895-21
  • ndc11
    58602-895-29
  • ndc11
    58602-895-35
  • ndc11
    58602-895-40
  • ndc11
    58602-895-41
  • ndc11
    58602-895-44
  • ndc11
    58602-895-46
  • ndc11
    58602-895-49
  • ndc11
    58602-895-51
  • ndc11
    58602-895-61
  • ndc11
    58602-895-62
  • ndc11
    58602-895-65
  • ndc11
    58602-895-73
  • ndc11
    58602-895-78

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Acetaminophen; ibuprofen in 14 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All acetaminophen; ibuprofen products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Combogesic, Comboval
  • Belgium · Brufen Plus Paracetamol, Combogesic
  • Bulgaria · Lekadol Complex, Nurulin Duo
  • Cyprus · Duomax, Edolfen Dual Action
  • Czechia · Brufen Combi, Cetalgen
  • Germany · Comboval, Duoval
  • Denmark · Comboval, Doleron
  • Estonia · Combogesic, Kivenul
  • Spain · Antidol Dual, Comboval
  • Finland · Comboval, Dolerin
  • France · Cetafen, Paracetamol/Ibuprofene Medipha
  • United Kingdom (Northern Ireland) · Combogesic, Combogesic Iv
  • Greece · Algofren Compositum, Combogesic
  • Croatia · Blokmax Duo, Brufen Akut Duo
  • Hungary · Advil Duo, Combogesic
  • Ireland · Combileve, Combileve 500 Mg/200 Mg Film-Coated Tablets
  • Iceland · Comboval, Paracetamol/Ibuprofen Vale Pharma
  • Italy · Combogesic, Paracetamolo E Ibuprofene Mylan
  • Lithuania · Adobil, Combogesic
  • Luxembourg · Brufen Plus Paracetamol, Combogesic
  • Latvia · Adobil, Combogesic
  • Malta · Combofusiv, Duomax
  • Netherlands · Comboval, Nuralgan
  • Norway · Comboval, Dolerin
  • Poland · 200 Mg + 500 Mg, Apap Intense
  • Portugal · Brufenon, Combofusiv
  • Romania · Advil Duo, Analgex
  • Sweden · Comboval, Dolerin
  • Slovenia · Adobil, Besta
  • Slovakia · Cetalgen, Combogesic

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/ce5cd07b-e516-43aa-9a67-714f53b5fdc8
GET /v1/drugs/ce5cd07b-e516-43aa-9a67-714f53b5fdc8?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "250; 125",
  "substance": "ACETAMINOPHEN; IBUPROFEN",
  "productndc": "58602-895",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA218359",
  "marketing_category": "ANDA"
}

See everything about acetaminophen; ibuprofen.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.