acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule

RxCUI: 1431286
RxNorm name: acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
Display name: Acetaminophen/Butalbital/Caffeine/Codeine (Oral Pill)
Full name: acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
Term type: SCD
Status: Active
Strength: 300-50-40-30 mg
Dose form: Cap
Route: Oral Pill
Updated: 2026-10-17 23:55:42

RxNorm Status History#

Status: Active
Source: RXNORM
Current: YES
Release start: 082013
Active start: 082013
Multiple ingredient: YES
Branded: NO

Ingredients And Strength#

Ingredient, Strength, Base table
Ingredient	Strength	Base	Basis of strength
acetaminophen	300 MG / 1 EACH	acetaminophen	acetaminophen
caffeine	40 MG / 1 EACH	caffeine	caffeine
butalbital	50 MG / 1 EACH	butalbital	butalbital
codeine phosphate	30 MG / 1 EACH	codeine	codeine phosphate

Dose Form Concepts#

Dose form, RxCUI table
Dose form	RxCUI
Oral Capsule	316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
Ingredient	RxCUI
acetaminophen	161
caffeine	1886
butalbital	19860
codeine	2670

Source Vocabulary Codes#

Code type, Values, Count table
Code type	Values	Count	Category
PRESCRIBABLE	Y	1	ATTRIBUTES
RXNAV_STR	acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	1	NAMES
RxNorm Name	acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	1	NAMES
RxNorm Synonym	APAP 300 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule	1	NAMES
TTY	SCD	1	ATTRIBUTES
SPL_SET_ID	2 linked values 6e0e8abc-512b-42f7-8323-434c589edecf 52321fe5-c001-4e2d-8149-3197ddc13764	2	CODES
RxCUI	1431286	1	CODES
MMSL_CODE	2 linked values BD28803 CD28803	2	CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
0054-0650-25	0054-0650	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA215138
0591-2641-01	0591-2641	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	ANDA076560

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
ANDA215138	0054-0650	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	ANDA	Hikma Pharmaceuticals USA Inc.
ANDA076560	0591-2641	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	ANDA	Actavis Pharma, Inc.

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11	Source	Active
00054065025	rxnav_ndcs	yes
00591264101	rxnav_ndcs	yes
00722702801	rxnav_historical
00722702805	rxnav_historical
79739702801	rxnav_historical
79739702805	rxnav_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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	Hikma Pharmaceuticals USA Inc.	6e0e8abc-512b-42f7-8323-434c589edecf	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 0054-0650-25 ndc (product): 0054-0650 ndc11 (package): 00054065025 rxcui: 1431286
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE	Actavis Pharma, Inc.	52321fe5-c001-4e2d-8149-3197ddc13764	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 0591-2641-01 ndc (product): 0591-2641 ndc11 (package): 00591264101 rxcui: 1431286

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 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
df9801fc-03fe-41da-a6b3-0f76788217c9	butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule [SY]	3	11	These highlights do not include all the information needed to use FIORICET with CODEINE safely and effectively. See full prescribing information for FIORICET with CODEINE. FIORICET ® with CODEINE (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules, for oral use, CIII Initial U.S. Approval: 1992	20210301
8f8c5c01-5859-4843-adf4-8116ddaedc90	butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule [SY]	3	11	These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII. Initial U.S. Approval: 1992	20200221
52321fe5-c001-4e2d-8149-3197ddc13764	butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule [SY]	3	10	These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992	20251210
6e0e8abc-512b-42f7-8323-434c589edecf	butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule [SY]	3	6	These highlights do not include all the information needed to use BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES safely and effectively. See full prescribing information for BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES. BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE capsules, for oral use, CIII Initial U.S. Approval: 1992	20260102
b96c0356-39e3-496a-a622-603f8a91f49e	butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule [SY]	3	2	These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII. Initial U.S. Approval: 1992	20210614

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
6e0e8abc-512b-42f7-8323-434c589edecf	These highlights do not include all the information needed to use BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES safely and effectively. See full prescribing information for BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES. BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE capsules, for oral use, CIII Initial U.S. Approval: 1992	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	20260102
52321fe5-c001-4e2d-8149-3197ddc13764	These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992	Actavis Pharma, Inc.	20251210
b96c0356-39e3-496a-a622-603f8a91f49e	These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII. Initial U.S. Approval: 1992	LGM Pharma Solutions, LLC	20210614
8f8c5c01-5859-4843-adf4-8116ddaedc90	These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII. Initial U.S. Approval: 1992	Nexgen Pharma, Inc.	20200221

Drug Classes#

Source, Class ID, Class table
Source	Class ID	Class	Type	Relationship	Drug concept
ATC	N02BE	Anilides	ATC1-4		acetaminophen
ATC	R05DA	Opium alkaloids and derivatives	ATC1-4		codeine
ATC	D11AX	Other dermatologicals	ATC1-4		caffeine
ATC	N06BC	Xanthine derivatives	ATC1-4		caffeine
FDASPL	D001463	Barbiturates	CHEM	has_chemical_structure	butalbital
FDASPL	D014970	Xanthines	CHEM	has_chemical_structure	caffeine
FDASPL	N0000175693	Barbiturate	EPC	has_epc	butalbital
FDASPL	N0000175739	Central Nervous System Stimulant	EPC	has_epc	caffeine
FDASPL	N0000175790	Methylxanthine	EPC	has_epc	caffeine
FDASPL	N0000175729	Central Nervous System Stimulation	PE	has_pe	caffeine
MEDRT	D000082	Acetaminophen	CHEM	has_ingredient	acetaminophen
MEDRT	D001463	Barbiturates	CHEM	has_ingredient	butalbital
MEDRT	D002110	Caffeine	CHEM	has_ingredient	caffeine
MEDRT	D003061	Codeine	CHEM	has_ingredient	codeine phosphate
MEDRT	D003061	Codeine	CHEM	has_ingredient	codeine
MEDRT	D009020	Morphine	CHEM	has_active_metabolites	codeine phosphate
MEDRT	D009020	Morphine	CHEM	has_active_metabolites	codeine
MEDRT	D001049	Apnea	DISEASE	may_treat	caffeine
MEDRT	D001249	Asthma	DISEASE	ci_with	codeine
MEDRT	D001249	Asthma	DISEASE	ci_with	codeine phosphate
MEDRT	D003371	Cough	DISEASE	may_treat	codeine
MEDRT	D003371	Cough	DISEASE	may_treat	codeine phosphate
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	acetaminophen
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	butalbital
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	codeine
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	caffeine
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	codeine phosphate
MEDRT	D005221	Fatigue	DISEASE	may_treat	caffeine
MEDRT	D005334	Fever	DISEASE	may_prevent	acetaminophen
MEDRT	D005334	Fever	DISEASE	may_treat	acetaminophen
MEDRT	D005955	Glucosephosphate Dehydrogenase Deficiency	DISEASE	ci_with	acetaminophen
MEDRT	D006261	Headache	DISEASE	may_treat	butalbital
MEDRT	D007415	Intestinal Obstruction	DISEASE	ci_with	codeine phosphate
MEDRT	D007415	Intestinal Obstruction	DISEASE	ci_with	codeine
MEDRT	D008107	Liver Diseases	DISEASE	ci_with	acetaminophen
MEDRT	D010146	Pain	DISEASE	may_treat	codeine phosphate
MEDRT	D010146	Pain	DISEASE	may_treat	codeine
MEDRT	D010146	Pain	DISEASE	may_treat	acetaminophen
MEDRT	D010146	Pain	DISEASE	may_prevent	acetaminophen
MEDRT	D011164	Porphyrias	DISEASE	ci_with	butalbital
MEDRT	D011247	Pregnancy	DISEASE	ci_with	codeine
MEDRT	D011247	Pregnancy	DISEASE	ci_with	butalbital
MEDRT	D011247	Pregnancy	DISEASE	ci_with	codeine phosphate
MEDRT	D012131	Respiratory Insufficiency	DISEASE	ci_with	codeine
MEDRT	D012131	Respiratory Insufficiency	DISEASE	ci_with	codeine phosphate
MEDRT	N0000000133	Enzyme Inhibitors	MOA	has_moa	caffeine
MEDRT	N0000175684	Full Opioid Agonists	MOA	has_moa	codeine
MEDRT	N0000175684	Full Opioid Agonists	MOA	has_moa	codeine phosphate
MEDRT	N0000000184	Monoamine Oxidase Inhibitors	MOA	ci_moa	codeine phosphate
MEDRT	N0000000184	Monoamine Oxidase Inhibitors	MOA	ci_moa	codeine
MEDRT	N0000000105	Neurotransmitter Transporter Interactions	MOA	has_moa	butalbital
MEDRT	N0000000108	Prostaglandin Receptor Antagonists	MOA	has_moa	acetaminophen
MEDRT	N0000175439	Analgesia	PE	has_pe	codeine phosphate
MEDRT	N0000175439	Analgesia	PE	has_pe	codeine
MEDRT	N0000008322	Bronchodilation	PE	has_pe	caffeine
MEDRT	N0000008331	Cardiovascular Activity Alteration	PE	has_pe	caffeine
MEDRT	N0000175724	Central Nervous System Activity Alteration	PE	has_pe	acetaminophen
MEDRT	N0000008567	Decreased Collecting Duct Water Permeability	PE	has_pe	caffeine
MEDRT	N0000008701	Decreased Medullary Respiratory Drive	PE	has_pe	codeine
MEDRT	N0000008701	Decreased Medullary Respiratory Drive	PE	has_pe	codeine phosphate
MEDRT	N0000008768	Decreased Organized Electrical Activity	PE	has_pe	codeine
MEDRT	N0000008768	Decreased Organized Electrical Activity	PE	has_pe	codeine phosphate
MEDRT	N0000008768	Decreased Organized Electrical Activity	PE	has_pe	butalbital
MEDRT	N0000008836	Decreased Prostaglandin Production	PE	has_pe	acetaminophen
MEDRT	N0000009072	Hypothalamic Endocrine Activity Alteration	PE	has_pe	acetaminophen
MEDRT	N0000009197	Increased Central Nervous System Organized Electrical Activity	PE	has_pe	caffeine
MEDRT	N0000175725	Peripheral Nervous System Activity Alteration	PE	has_pe	acetaminophen
MEDRT	N0000000026	Hepatic Metabolism	PK	has_pk	acetaminophen
MEDRT	N0000000026	Hepatic Metabolism	PK	site_of_metabolism	codeine phosphate
MEDRT	N0000000026	Hepatic Metabolism	PK	has_pk	codeine phosphate
MEDRT	N0000000026	Hepatic Metabolism	PK	site_of_metabolism	codeine
MEDRT	N0000000026	Hepatic Metabolism	PK	has_pk	codeine
MEDRT	N0000000042	Renal Excretion	PK	has_pk	codeine phosphate
MEDRT	N0000000042	Renal Excretion	PK	has_pk	acetaminophen
MEDRT	N0000000042	Renal Excretion	PK	has_pk	codeine

Group, Type, Concept table
Group	Type	Concept	Source
BN	BN	Fioricet with Codeine	rxnav_allrelated
DF	DF	Oral Capsule	rxnav_allrelated
DFG	DFG	Oral Product	rxnav_allrelated
DFG	DFG	Pill	rxnav_allrelated
IN	IN	acetaminophen	rxnav_allrelated
IN	IN	butalbital	rxnav_allrelated
IN	IN	caffeine	rxnav_allrelated
IN	IN	codeine	rxnav_allrelated
MIN	MIN	acetaminophen / butalbital / caffeine / codeine	rxnav_allrelated
PIN	PIN	codeine phosphate	rxnav_allrelated
SBD	SBD	acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [Fioricet with Codeine]	rxnav_allrelated
SBDC	SBDC	acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG [Fioricet with Codeine]	rxnav_allrelated
SBDF	SBDF	acetaminophen / butalbital / caffeine / codeine Oral Capsule [Fioricet with Codeine]	rxnav_allrelated
SBDFP	SBDFP	acetaminophen / butalbital / caffeine / codeine phosphate Oral Capsule [Fioricet with Codeine]	rxnav_allrelated
SBDG	SBDG	Fioricet with Codeine Oral Product	rxnav_allrelated
SBDG	SBDG	Fioricet with Codeine Pill	rxnav_allrelated
SCD	SCD	acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	rxnav_allrelated
SCDC	SCDC	acetaminophen 300 MG	rxnav_allrelated
SCDC	SCDC	butalbital 50 MG	rxnav_allrelated
SCDC	SCDC	caffeine 40 MG	rxnav_allrelated
SCDC	SCDC	codeine phosphate 30 MG	rxnav_allrelated
SCDF	SCDF	acetaminophen / butalbital / caffeine / codeine Oral Capsule	rxnav_allrelated
SCDFP	SCDFP	acetaminophen / butalbital / caffeine / codeine phosphate Oral Capsule	rxnav_allrelated
SCDG	SCDG	acetaminophen / butalbital / caffeine / codeine Oral Product	rxnav_allrelated
SCDG	SCDG	acetaminophen / butalbital / caffeine / codeine Pill	rxnav_allrelated
SCDGP	SCDGP	acetaminophen / butalbital / caffeine / codeine phosphate Oral Product	rxnav_allrelated
SCDGP	SCDGP	acetaminophen / butalbital / caffeine / codeine phosphate Pill	rxnav_allrelated

Properties#

Category, Property, Value table
Category	Property	Value
ATTRIBUTES	AVAILABLE_STRENGTH	300 MG / 50 MG / 40 MG / 30 MG
ATTRIBUTES	GENERAL_CARDINALITY	MULTI
ATTRIBUTES	HUMAN_DRUG	US
ATTRIBUTES	RXNAV_HUMAN_DRUG	US
ATTRIBUTES	SCHEDULE	3
CODES	ANDA	ANDA076560
CODES	ANDA	ANDA215138
CODES	VUID	4032595
NAMES	Prescribable Synonym	butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
SOURCES	Source	Gold Standard Alchemy
SOURCES	Source	Metathesaurus FDA Structured Product Labels
SOURCES	Source	Micromedex RED BOOK
SOURCES	Source	Multum MediSource Lexicon
SOURCES	Source	National Drug Data File Plus Source Vocabulary
SOURCES	Source	Veterans Health Administration National Drug File