FDA.reportPublic FDA data

acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]

RxCUI
1190201
RxNorm name
acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]
Display name
TREZIX (Oral Pill)
Full name
acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]
Term type
SBD
Status
Active
Strength
320.5-30-16 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-07-20 06:51:48

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112011
Active start
112011
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen320.5 MG / 1 EACHacetaminophenacetaminophen
caffeine30 MG / 1 EACHcaffeinecaffeine
dihydrocodeine bitartrate16 MG / 1 EACHdihydrocodeinedihydrocodeine bitartrate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
caffeine1886
dihydrocodeine23088

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRAPAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]NAMES
RxNorm Nameacetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]NAMES
RxNorm SynonymAPAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]NAMES
RxNorm SynonymTrezix (acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG) Oral CapsuleNAMES
TTYSBDATTRIBUTES
SPL_SET_ID45c3c2a1-6a89-471e-b6d4-5a4cd73b987aCODES
RxCUI1190201CODES
MMSL_CODEBD30013CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63187-705-0063187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDA204785
63187-705-3063187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDA204785
63187-705-6063187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDA204785
63187-705-7263187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDA204785
63187-705-9063187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDA204785

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20478563187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateANDAProficient Rx LP

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 11 matching rows.

NDC11, Source, Active table
NDC11SourceActive
63187070500rxnav_ndcsyes
63187070530rxnav_ndcsyes
63187070560rxnav_ndcsyes
63187070572rxnav_ndcsyes
63187070590rxnav_ndcsyes
63629563701rxnav_ndcsyes
63629563702rxnav_ndcsyes
63629563703rxnav_ndcsyes
63629563704rxnav_ndcsyes
66992084010rxnav_ndcsyes
66992034010rxnav_historical

UNII Substances#

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

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrezixACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEProficient Rx LP45c3c2a1-6a89-471e-b6d4-5a4cd73b987a2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63187-705-60
ndc (package): 63187-705-00
ndc (package): 63187-705-90
ndc (package): 63187-705-72
ndc (package): 63187-705-30
ndc (product): 63187-705
ndc11 (package): 63187070572
ndc11 (package): 63187070500
ndc11 (package): 63187070530
ndc11 (package): 63187070590
ndc11 (package): 63187070560
rxcui: 1190201

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a519a201-bcfd-4029-9bdf-fc3e03f975acacetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]SBD12TREZIX™ Capsules20210203
a519a201-bcfd-4029-9bdf-fc3e03f975acTrezix (acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG) Oral CapsuleSY12TREZIX™ Capsules20210203
a519a201-bcfd-4029-9bdf-fc3e03f975acAPAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]SY12TREZIX™ Capsules20210203
a519a201-bcfd-4029-9bdf-fc3e03f975acTREZIX 16 MG / 320.5 MG / 30 MG Oral CapsulePSN12TREZIX™ Capsules20210203
45c3c2a1-6a89-471e-b6d4-5a4cd73b987aAPAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]SY6TREZIX™ Capsules20220502
45c3c2a1-6a89-471e-b6d4-5a4cd73b987aTrezix (acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG) Oral CapsuleSY6TREZIX™ Capsules20220502
45c3c2a1-6a89-471e-b6d4-5a4cd73b987aacetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]SBD6TREZIX™ Capsules20220502
45c3c2a1-6a89-471e-b6d4-5a4cd73b987aTREZIX 16 MG / 320.5 MG / 30 MG Oral CapsulePSN6TREZIX™ Capsules20220502

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
45c3c2a1-6a89-471e-b6d4-5a4cd73b987aTREZIX™ CapsulesProficient Rx LP20220502
f90f87cb-77ad-45f4-8b59-09459090d988TREZIX™ CapsulesBryant Ranch Prepack20211222
a519a201-bcfd-4029-9bdf-fc3e03f975acTREZIX™ CapsulesWraser Llc20210203
e39685de-c542-4cce-bf11-041c4d933061National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
ATCN02AANatural opium alkaloidsATC1-4dihydrocodeine
ATCD11AXOther dermatologicalsATC1-4caffeine
ATCN06BCXanthine derivativesATC1-4caffeine
FDASPLD014970XanthinesCHEMhas_chemical_structurecaffeine
FDASPLN0000175739Central Nervous System StimulantEPChas_epccaffeine
FDASPLN0000175790MethylxanthineEPChas_epccaffeine
FDASPLN0000175690Opioid AgonistEPChas_epcdihydrocodeine
FDASPLN0000175684Full Opioid AgonistsMOAhas_moadihydrocodeine
FDASPLN0000175729Central Nervous System StimulationPEhas_pecaffeine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD002110CaffeineCHEMhas_ingredientcaffeine
MEDRTD003061CodeineCHEMhas_ingredientdihydrocodeine
MEDRTD003061CodeineCHEMhas_ingredientdihydrocodeine bitartrate
MEDRTD001049ApneaDISEASEmay_treatcaffeine
MEDRTD001249AsthmaDISEASEci_withdihydrocodeine
MEDRTD001249AsthmaDISEASEci_withdihydrocodeine bitartrate
MEDRTD002648ChildDISEASEci_withdihydrocodeine
MEDRTD002648ChildDISEASEci_withdihydrocodeine bitartrate
MEDRTD003371CoughDISEASEmay_treatdihydrocodeine bitartrate
MEDRTD003371CoughDISEASEmay_treatdihydrocodeine
MEDRTD004342Drug HypersensitivityDISEASEci_withdihydrocodeine bitartrate
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withcaffeine
MEDRTD004342Drug HypersensitivityDISEASEci_withdihydrocodeine
MEDRTD005221FatigueDISEASEmay_treatcaffeine
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD007415Intestinal ObstructionDISEASEci_withdihydrocodeine bitartrate
MEDRTD007415Intestinal ObstructionDISEASEci_withdihydrocodeine
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_treatdihydrocodeine
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_treatdihydrocodeine bitartrate
MEDRTD011247PregnancyDISEASEci_withdihydrocodeine
MEDRTD011247PregnancyDISEASEci_withdihydrocodeine bitartrate
MEDRTD012131Respiratory InsufficiencyDISEASEci_withdihydrocodeine
MEDRTD012131Respiratory InsufficiencyDISEASEci_withdihydrocodeine bitartrate
MEDRTN0000000133Enzyme InhibitorsMOAhas_moacaffeine
MEDRTN0000175684Full Opioid AgonistsMOAhas_moadihydrocodeine
MEDRTN0000175684Full Opioid AgonistsMOAhas_moadihydrocodeine bitartrate
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175439AnalgesiaPEhas_pedihydrocodeine bitartrate
MEDRTN0000175439AnalgesiaPEhas_pedihydrocodeine
MEDRTN0000008322BronchodilationPEhas_pecaffeine
MEDRTN0000008331Cardiovascular Activity AlterationPEhas_pecaffeine
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000175728Central Nervous System DepressionPEci_pedihydrocodeine bitartrate
MEDRTN0000175728Central Nervous System DepressionPEci_pedihydrocodeine
MEDRTN0000008567Decreased Collecting Duct Water PermeabilityPEhas_pecaffeine
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pedihydrocodeine
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pedihydrocodeine bitartrate
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000009197Increased Central Nervous System Organized Electrical ActivityPEhas_pecaffeine
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH320.5 MG / 30 MG / 16 MG (expressed as dihydrocodeine bitartrate)
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE3
ATTRIBUTESTTYSBD
CODESANDAANDA204785
CODESMMSL_CODEBD30013
CODESRxCUI1190201
CODESSPL_SET_ID45c3c2a1-6a89-471e-b6d4-5a4cd73b987a
NAMESPrescribable SynonymTREZIX 16 MG / 320.5 MG / 30 MG Oral Capsule
NAMESRXNAV_STRAPAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]
NAMESRxNorm Nameacetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]
NAMESRxNorm SynonymAPAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]
NAMESRxNorm SynonymTrezix (acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG) Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon