FDA.reportPublic FDA data

acetaminophen 65 MG/ML / oxycodone hydrochloride 1 MG/ML Oral Solution

RxCUI
1049580
RxNorm name
acetaminophen 65 MG/ML / oxycodone hydrochloride 1 MG/ML Oral Solution
Display name
Acetaminophen/oxyCODONE (Oral Liquid)
Full name
acetaminophen 65 MG/ML / oxycodone hydrochloride 1 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
325-5 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-10-17 23:43:58

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012011
Active start
012011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen65 MG / 1 MLacetaminophenacetaminophen
oxycodone hydrochloride1 MG / 1 MLoxycodoneoxycodone hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
oxycodone7804

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRacetaminophen 65 MG/ML / oxyCODONE hydrochloride 1 MG/ML Oral Solution1NAMES
RxNorm Nameacetaminophen 65 MG/ML / oxycodone hydrochloride 1 MG/ML Oral Solution1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID9986aa04-c976-4654-8ad7-b97d2eecea931CODES
RxCUI10495801CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
10702-238-5010702-238OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophenKVK-Tech, Inc.ANDA211499

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA21149910702-238OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophenANDAKVK-Tech, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 6 matching rows.

NDC11, Source, Active table
NDC11SourceActive
10702023850rxnav_ndcsyes
29033040535rxnav_ndcsyes
00054368663rxnav_historical_indirect
00054864816rxnav_historical_indirect
00406855350rxnav_historical
00603149215rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENKVK-Tech, Inc.9986aa04-c976-4654-8ad7-b97d2eecea932026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 10702-238-50
ndc (product): 10702-238
ndc11 (package): 10702023850
rxcui: 1049580

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9986aa04-c976-4654-8ad7-b97d2eecea93oxyCODONE HCl 5 MG / acetaminophen 325 MG in 5 mL Oral Solution [PSN] · acetaminophen 65 MG/ML / oxycodone hydrochloride 1 MG/ML Oral Solution [SCD] · APAP 325 MG / oxycodone hydrochloride 5 MG per 5 ML Oral Solution [SY] · APAP 65 MG/ML / Oxycodone Hydrochloride 1 MG/ML Oral Solution [SY]415Oxycodone Hydrochloride and Acetaminophen Oral Solution, CII Rx only Revised January 202620260112
b3f5d46d-d807-4db9-abbd-9f0da4548283oxyCODONE HCl 5 MG / acetaminophen 325 MG in 5 mL Oral Solution [PSN] · acetaminophen 65 MG/ML / oxycodone hydrochloride 1 MG/ML Oral Solution [SCD] · APAP 325 MG / oxycodone hydrochloride 5 MG per 5 ML Oral Solution [SY] · APAP 65 MG/ML / Oxycodone Hydrochloride 1 MG/ML Oral Solution [SY]41Oxycodone Hydrochloride and Acetaminophen Oral Solution 5 mg/325 mg per 5 mL Rx Only20210908

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
9986aa04-c976-4654-8ad7-b97d2eecea93Oxycodone Hydrochloride and Acetaminophen Oral Solution, CII Rx only Revised January 2026KVK-Tech, Inc. | ABHAI, LLC.20260112
b3f5d46d-d807-4db9-abbd-9f0da4548283Oxycodone Hydrochloride and Acetaminophen Oral Solution 5 mg/325 mg per 5 mL Rx OnlyNostrum Laboratories, Inc.20210908
86817b05-450c-4af0-aeea-acba2ac00601ROXICET™ CII Oxycodone 5 mg and Acetaminophen 325 mg Tablets, USP Oxycodone 5 mg and Acetaminophen 325 mg Oral Solution per 5 mLWest-Ward Pharmaceuticals Corp | West-Ward Columbus Inc. | Noramco Inc. (DE) | Noramco Inc. (GA) | Rhodia Wuxi Pharmaceutical Co., Ltd. | Mallinckrodt Inc.20160812
111b8cd3-7b2e-4c0c-a867-6d776d13190dNational Council for Prescription Drug Programs20120724
433b6eff-3f73-4307-a601-6553646b6792National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
ATCN02AANatural opium alkaloidsATC1-4oxycodone
FDASPLN0000175690Opioid AgonistEPChas_epcoxycodone
FDASPLN0000175684Full Opioid AgonistsMOAhas_moaoxycodone
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD010098OxycodoneCHEMhas_ingredientoxycodone
MEDRTD010098OxycodoneCHEMhas_ingredientoxycodone hydrochloride
MEDRTD001249AsthmaDISEASEci_withoxycodone hydrochloride
MEDRTD001249AsthmaDISEASEci_withoxycodone
MEDRTD004342Drug HypersensitivityDISEASEci_withoxycodone hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withoxycodone
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD007415Intestinal ObstructionDISEASEci_withoxycodone hydrochloride
MEDRTD007415Intestinal ObstructionDISEASEci_withoxycodone
MEDRTD007418Intestinal Pseudo-ObstructionDISEASEci_withoxycodone
MEDRTD007418Intestinal Pseudo-ObstructionDISEASEci_withoxycodone hydrochloride
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010149Postoperative PainDISEASEmay_treatoxycodone hydrochloride
MEDRTD010149Postoperative PainDISEASEmay_treatoxycodone
MEDRTD011247PregnancyDISEASEci_withoxycodone
MEDRTD011247PregnancyDISEASEci_withoxycodone hydrochloride
MEDRTD012131Respiratory InsufficiencyDISEASEci_withoxycodone hydrochloride
MEDRTD012131Respiratory InsufficiencyDISEASEci_withoxycodone
MEDRTN0000175684Full Opioid AgonistsMOAhas_moaoxycodone hydrochloride
MEDRTN0000175684Full Opioid AgonistsMOAhas_moaoxycodone
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175439AnalgesiaPEhas_peoxycodone hydrochloride
MEDRTN0000175439AnalgesiaPEhas_peoxycodone
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008635Decreased GI MotilityPEhas_peoxycodone
MEDRTN0000008635Decreased GI MotilityPEhas_peoxycodone hydrochloride
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_peoxycodone
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_peoxycodone hydrochloride
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_peoxycodone
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_peoxycodone hydrochloride
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000009353Increased Histamine ProductionPEhas_peoxycodone hydrochloride
MEDRTN0000009353Increased Histamine ProductionPEhas_peoxycodone
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH65 MG/ML / 1 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE2
CODESANDAANDA211499
CODESVUID4003070
NAMESPrescribable SynonymoxyCODONE HCl 5 MG / acetaminophen 325 MG in 5 mL Oral Solution
NAMESTallman Synonymacetaminophen 65 MG/ML / oxyCODONE hydrochloride 1 MG/ML Oral Solution
NAMESTallman SynonymAPAP 325 MG / oxyCODONE hydrochloride 5 MG per 5 ML Oral Solution
NAMESTallman SynonymAPAP 65 MG/ML / oxyCODONE Hydrochloride 1 MG/ML Oral Solution
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary