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.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
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
- ndc1158602-895-82
- ndc1158602-895-84
- ndc1158602895011 BOTTLE, PLASTIC in 1 CARTON (58602-895-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc1158602895031 BOTTLE in 1 CARTON (58602-895-03) / 10 TABLET, FILM COATED in 1 BOTTLE
- ndc1158602895071 BOTTLE in 1 CARTON (58602-895-07) / 24 TABLET, FILM COATED in 1 BOTTLE
- ndc1158602895111 BOTTLE in 1 CARTON (58602-895-11) / 36 TABLET, FILM COATED in 1 BOTTLE
- ndc1158602895141 BOTTLE in 1 CARTON (58602-895-14) / 50 TABLET, FILM COATED in 1 BOTTLE
- ndc1158602895211 BOTTLE in 1 CARTON (58602-895-21) / 100 TABLET, FILM COATED in 1 BOTTLE
- ndc1158602895291 BOTTLE in 1 CARTON (58602-895-29) / 150 TABLET, FILM COATED in 1 BOTTLE
- ndc115860289535225 TABLET, FILM COATED in 1 BOTTLE (58602-895-35)
- ndc115860289540500 TABLET, FILM COATED in 1 BOTTLE (58602-895-40)
- ndc1158602895411000 TABLET, FILM COATED in 1 BOTTLE (58602-895-41)
- ndc115860289544400 TABLET, FILM COATED in 1 BOTTLE (58602-895-44)
- ndc1158602895461 BOTTLE, PLASTIC in 1 CARTON (58602-895-46) / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc1158602895491 BOTTLE, PLASTIC in 1 CARTON (58602-895-49) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc115860289551216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-51)
- ndc1158602895611 BLISTER PACK in 1 CARTON (58602-895-61) / 2 TABLET, FILM COATED in 1 BLISTER PACK
- ndc115860289562216 TABLET, FILM COATED in 1 BOTTLE (58602-895-62)
- ndc1158602895651 BOTTLE in 1 CARTON (58602-895-65) / 72 TABLET, FILM COATED in 1 BOTTLE
- ndc1158602895731 BOTTLE in 1 CARTON (58602-895-73) / 20 TABLET, FILM COATED in 1 BOTTLE
- ndc1158602895781 BOTTLE, PLASTIC in 1 CARTON (58602-895-78) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc115860289579500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-79)
- ndc1158602895801 BOTTLE, PLASTIC in 1 CARTON (58602-895-80) / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc1158602895821 BOTTLE in 1 CARTON (58602-895-82) / 18 TABLET, FILM COATED in 1 BOTTLE
- ndc115860289584225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-84)
- ndc1158602895851 BOTTLE, PLASTIC in 1 CARTON (58602-895-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc115860289588750 TABLET, FILM COATED in 1 BOTTLE (58602-895-88)
- ndc1158602895941 BOTTLE, PLASTIC in 1 CARTON (58602-895-94) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc115860289595750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-95)
- ndc1158602895961 BOTTLE, PLASTIC in 1 CARTON (58602-895-96) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc115860289599400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-99)
- ndc1158602-895-01
- ndc1158602-895-03
- ndc1158602-895-07
- ndc1158602-895-11
- ndc1158602-895-14
- ndc1158602-895-21
- ndc1158602-895-29
- ndc1158602-895-35
- ndc1158602-895-40
- ndc1158602-895-41
- ndc1158602-895-44
- ndc1158602-895-46
- ndc1158602-895-49
- ndc1158602-895-51
- ndc1158602-895-61
- ndc1158602-895-62
- ndc1158602-895-65
- ndc1158602-895-73
- ndc1158602-895-78
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.
- CzechiaBRUFEN COMBIVIATRIS LIMITED, Dublin
- PolandAPAP intenseUS Pharmacia Sp. z o.o.
- GermanyCombovalEver Valinject Gmbh
- SpainANTIDOL DUAL 500 MG/200 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULALaboratorios Cinfa S.A.
- United KingdomBell's Dual Action Pain Relief 200mg/500mg tabletsBell,Sons & Co (Druggists) Ltd
- SwitzerlandAlgifor Dolo Duo 500mg/150mg, FilmtablettenVerfora SA
- SwedenComboval 10 mg/ml +3 mg/ml Infusionsvätska, lösningLaboratoire Aguettant
- NetherlandsComboval 10 mg/ml + 3 mg/ml oplossing voor infusieLaboratoire Aguettant
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.