acetaminophen 325 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet

RxCUI: 1673869
RxNorm name: acetaminophen 325 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
Display name: Acetaminophen/Dextromethorphan/guaiFENesin/Pseudoephedrine (Oral Pill)
Full name: acetaminophen 325 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
Term type: SCD
Status: Active
Strength: 325-20-200-60 mg
Dose form: Tab
Route: Oral Pill
Updated: 2026-10-21 00:28:18

RxNorm Status History#

Status: Active
Source: RXNORM
Current: YES
Release start: 112015
Active start: 112015
Multiple ingredient: YES
Branded: NO

Ingredients And Strength#

Ingredient, Strength, Base table
Ingredient	Strength	Base	Basis of strength
acetaminophen	325 MG / 1 EACH	acetaminophen	acetaminophen
dextromethorphan hydrobromide	20 MG / 1 EACH	dextromethorphan	dextromethorphan hydrobromide
guaifenesin	200 MG / 1 EACH	guaifenesin	guaifenesin
pseudoephedrine hydrochloride	60 MG / 1 EACH	pseudoephedrine	pseudoephedrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose form	RxCUI
Oral Tablet	317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
Ingredient	RxCUI
acetaminophen	161
dextromethorphan	3289
guaifenesin	5032
pseudoephedrine	8896

Source Vocabulary Codes#

Code type, Values, Count table
Code type	Values	Count	Category
PRESCRIBABLE	Y	1	ATTRIBUTES
RXNAV_STR	acetaminophen 325 MG / dextromethorphan hydrobromide 20 MG / guaiFENesin 200 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet	1	NAMES
RxNorm Name	acetaminophen 325 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet	1	NAMES
RxNorm Synonym	APAP 325 MG / Dextromethorphan Hydrobromide 20 MG / Guaifenesin 200 MG / Pseudoephedrine Hydrochloride 60 MG Oral Tablet	1	NAMES
TTY	SCD	1	ATTRIBUTES
SPL_SET_ID	55fffc1d-8449-4c28-a391-c6f60dd85622	1	CODES
RxCUI	1673869	1	CODES
MMSL_CODE	2 linked values BD30481 CD30481	2	CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
50991-535-01	50991-535	Duraflu ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl	Poly Pharmaceuticals, Inc.	M012
50991-535-02	50991-535	Duraflu ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl	Poly Pharmaceuticals, Inc.	M012

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
M012	50991-535	Duraflu ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl	OTC MONOGRAPH DRUG	Poly Pharmaceuticals, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 2 matching rows.

NDC11, Source, Active table
NDC11	Source	Active
50991053501	rxnav_ndcs	yes
50991053502	rxnav_ndcs	yes

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duraflu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	55fffc1d-8449-4c28-a391-c6f60dd85622	2024-11-09	Warnings	Exact identifier ndc (package): 50991-535-01 ndc (package): 50991-535-02 ndc (product): 50991-535 ndc11 (package): 50991053501 ndc11 (package): 50991053502 rxcui: 1673869

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
55fffc1d-8449-4c28-a391-c6f60dd85622	acetaminophen 325 MG / dextromethorphan HBr 20 MG / guaiFENesin 200 MG / pseudoephedrine HCl 60 MG Oral Tablet [PSN] · acetaminophen 325 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet [SCD] · APAP 325 MG / Dextromethorphan Hydrobromide 20 MG / Guaifenesin 200 MG / Pseudoephedrine Hydrochloride 60 MG Oral Tablet [SY]	3	8	Duraflu Tablets	20241109

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
55fffc1d-8449-4c28-a391-c6f60dd85622	Duraflu Tablets	Poly Pharmaceuticals, Inc.	20241109

Drug Classes#

Source, Class ID, Class table
Source	Class ID	Class	Type	Relationship	Drug concept
ATC	N02BE	Anilides	ATC1-4		acetaminophen
ATC	R05CA	Expectorants	ATC1-4		guaifenesin
ATC	R05DA	Opium alkaloids and derivatives	ATC1-4		dextromethorphan
ATC	R01BA	Sympathomimetics	ATC1-4		pseudoephedrine
FDASPL	N0000175552	alpha-Adrenergic Agonist	EPC	has_epc	pseudoephedrine
FDASPL	N0000193956	Expectorant	EPC	has_epc	guaifenesin
FDASPL	N0000182149	Sigma-1 Agonist	EPC	has_epc	dextromethorphan
FDASPL	N0000181821	Uncompetitive N-methyl-D-aspartate Receptor Antagonist	EPC	has_epc	dextromethorphan
FDASPL	N0000182147	Sigma-1 Receptor Agonists	MOA	has_moa	dextromethorphan
FDASPL	N0000181819	Uncompetitive NMDA Receptor Antagonists	MOA	has_moa	dextromethorphan
MEDRT	D000082	Acetaminophen	CHEM	has_ingredient	acetaminophen
MEDRT	D003915	Dextromethorphan	CHEM	has_ingredient	dextromethorphan
MEDRT	D003915	Dextromethorphan	CHEM	has_ingredient	dextromethorphan hydrobromide
MEDRT	D006140	Guaifenesin	CHEM	has_ingredient	guaifenesin
MEDRT	D054199	Pseudoephedrine	CHEM	has_ingredient	pseudoephedrine
MEDRT	D054199	Pseudoephedrine	CHEM	has_ingredient	pseudoephedrine hydrochloride
MEDRT	D001249	Asthma	DISEASE	may_treat	pseudoephedrine
MEDRT	D001249	Asthma	DISEASE	may_treat	pseudoephedrine hydrochloride
MEDRT	D001991	Bronchitis	DISEASE	may_treat	guaifenesin
MEDRT	D003139	Common Cold	DISEASE	may_treat	guaifenesin
MEDRT	D003139	Common Cold	DISEASE	may_treat	pseudoephedrine hydrochloride
MEDRT	D003139	Common Cold	DISEASE	may_treat	pseudoephedrine
MEDRT	D003371	Cough	DISEASE	may_treat	guaifenesin
MEDRT	D003371	Cough	DISEASE	may_treat	dextromethorphan hydrobromide
MEDRT	D003371	Cough	DISEASE	may_treat	dextromethorphan
MEDRT	D003371	Cough	DISEASE	may_prevent	dextromethorphan
MEDRT	D003371	Cough	DISEASE	may_prevent	dextromethorphan hydrobromide
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	pseudoephedrine
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	acetaminophen
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	guaifenesin
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	dextromethorphan hydrobromide
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	pseudoephedrine hydrochloride
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	dextromethorphan
MEDRT	D005334	Fever	DISEASE	may_prevent	acetaminophen
MEDRT	D005334	Fever	DISEASE	may_treat	acetaminophen
MEDRT	D005955	Glucosephosphate Dehydrogenase Deficiency	DISEASE	ci_with	acetaminophen
MEDRT	D007827	Laryngitis	DISEASE	may_treat	guaifenesin
MEDRT	D008107	Liver Diseases	DISEASE	ci_with	acetaminophen
MEDRT	D010146	Pain	DISEASE	may_treat	acetaminophen
MEDRT	D010146	Pain	DISEASE	may_prevent	acetaminophen
MEDRT	D010612	Pharyngitis	DISEASE	may_treat	guaifenesin
MEDRT	D012221	Rhinitis, Allergic, Perennial	DISEASE	may_treat	pseudoephedrine hydrochloride
MEDRT	D012221	Rhinitis, Allergic, Perennial	DISEASE	may_treat	pseudoephedrine
MEDRT	D012221	Rhinitis, Allergic, Perennial	DISEASE	may_treat	guaifenesin
MEDRT	D012852	Sinusitis	DISEASE	may_treat	pseudoephedrine hydrochloride
MEDRT	D012852	Sinusitis	DISEASE	may_treat	guaifenesin
MEDRT	D012852	Sinusitis	DISEASE	may_treat	pseudoephedrine
MEDRT	D014917	Whooping Cough	DISEASE	may_treat	guaifenesin
MEDRT	N0000000209	Adrenergic alpha-Agonists	MOA	has_moa	pseudoephedrine
MEDRT	N0000000209	Adrenergic alpha-Agonists	MOA	has_moa	pseudoephedrine hydrochloride
MEDRT	N0000000245	Adrenergic beta-Agonists	MOA	has_moa	pseudoephedrine hydrochloride
MEDRT	N0000000245	Adrenergic beta-Agonists	MOA	has_moa	pseudoephedrine
MEDRT	N0000000184	Monoamine Oxidase Inhibitors	MOA	ci_moa	pseudoephedrine
MEDRT	N0000000184	Monoamine Oxidase Inhibitors	MOA	ci_moa	dextromethorphan hydrobromide
MEDRT	N0000000184	Monoamine Oxidase Inhibitors	MOA	ci_moa	pseudoephedrine hydrochloride
MEDRT	N0000000184	Monoamine Oxidase Inhibitors	MOA	ci_moa	dextromethorphan
MEDRT	N0000000108	Prostaglandin Receptor Antagonists	MOA	has_moa	acetaminophen
MEDRT	N0000000109	Serotonin Uptake Inhibitors	MOA	has_moa	dextromethorphan
MEDRT	N0000000109	Serotonin Uptake Inhibitors	MOA	has_moa	dextromethorphan hydrobromide
MEDRT	N0000182147	Sigma-1 Receptor Agonists	MOA	has_moa	dextromethorphan hydrobromide
MEDRT	N0000182147	Sigma-1 Receptor Agonists	MOA	has_moa	dextromethorphan
MEDRT	N0000181819	Uncompetitive NMDA Receptor Antagonists	MOA	has_moa	dextromethorphan hydrobromide
MEDRT	N0000181819	Uncompetitive NMDA Receptor Antagonists	MOA	has_moa	dextromethorphan
MEDRT	N0000008322	Bronchodilation	PE	has_pe	pseudoephedrine hydrochloride
MEDRT	N0000008322	Bronchodilation	PE	has_pe	pseudoephedrine
MEDRT	N0000175724	Central Nervous System Activity Alteration	PE	has_pe	acetaminophen
MEDRT	N0000008701	Decreased Medullary Respiratory Drive	PE	has_pe	dextromethorphan hydrobromide
MEDRT	N0000008701	Decreased Medullary Respiratory Drive	PE	has_pe	dextromethorphan
MEDRT	N0000008836	Decreased Prostaglandin Production	PE	has_pe	acetaminophen
MEDRT	N0000008867	Decreased Respiratory Secretion Viscosity	PE	has_pe	guaifenesin
MEDRT	N0000009072	Hypothalamic Endocrine Activity Alteration	PE	has_pe	acetaminophen
MEDRT	N0000009560	Increased Respiratory Secretions	PE	has_pe	guaifenesin
MEDRT	N0000175725	Peripheral Nervous System Activity Alteration	PE	has_pe	acetaminophen
MEDRT	N0000009908	Vasoconstriction	PE	has_pe	pseudoephedrine
MEDRT	N0000009908	Vasoconstriction	PE	has_pe	pseudoephedrine hydrochloride
MEDRT	N0000000026	Hepatic Metabolism	PK	has_pk	acetaminophen
MEDRT	N0000000042	Renal Excretion	PK	has_pk	acetaminophen

Group, Type, Concept table
Group	Type	Concept	Source
DF	DF	Oral Tablet	rxnav_allrelated
DFG	DFG	Oral Product	rxnav_allrelated
DFG	DFG	Pill	rxnav_allrelated
IN	IN	acetaminophen	rxnav_allrelated
IN	IN	dextromethorphan	rxnav_allrelated
IN	IN	guaifenesin	rxnav_allrelated
IN	IN	pseudoephedrine	rxnav_allrelated
MIN	MIN	acetaminophen / dextromethorphan / guaifenesin / pseudoephedrine	rxnav_allrelated
PIN	PIN	dextromethorphan hydrobromide	rxnav_allrelated
PIN	PIN	pseudoephedrine hydrochloride	rxnav_allrelated
SCD	SCD	acetaminophen 325 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet	rxnav_allrelated
SCDC	SCDC	acetaminophen 325 MG	rxnav_allrelated
SCDC	SCDC	dextromethorphan hydrobromide 20 MG	rxnav_allrelated
SCDC	SCDC	guaifenesin 200 MG	rxnav_allrelated
SCDC	SCDC	pseudoephedrine hydrochloride 60 MG	rxnav_allrelated
SCDF	SCDF	acetaminophen / dextromethorphan / guaifenesin / pseudoephedrine Oral Tablet	rxnav_allrelated
SCDFP	SCDFP	acetaminophen / dextromethorphan hydrobromide / guaifenesin / pseudoephedrine hydrochloride Oral Tablet	rxnav_allrelated
SCDG	SCDG	acetaminophen / dextromethorphan / guaifenesin / pseudoephedrine Oral Product	rxnav_allrelated
SCDG	SCDG	acetaminophen / dextromethorphan / guaifenesin / pseudoephedrine Pill	rxnav_allrelated
SCDGP	SCDGP	acetaminophen / dextromethorphan hydrobromide / guaifenesin / pseudoephedrine hydrochloride Oral Product	rxnav_allrelated
SCDGP	SCDGP	acetaminophen / dextromethorphan hydrobromide / guaifenesin / pseudoephedrine hydrochloride Pill	rxnav_allrelated

Properties#

Category, Property, Value table
Category	Property	Value
ATTRIBUTES	AVAILABLE_STRENGTH	325 MG / 20 MG / 200 MG / 60 MG
ATTRIBUTES	GENERAL_CARDINALITY	MULTI
ATTRIBUTES	HUMAN_DRUG	US
ATTRIBUTES	RXNAV_HUMAN_DRUG	US
ATTRIBUTES	SCHEDULE	0
CODES	VUID	4035041
NAMES	Prescribable Synonym	acetaminophen 325 MG / dextromethorphan HBr 20 MG / guaiFENesin 200 MG / pseudoephedrine HCl 60 MG Oral Tablet
NAMES	Tallman Synonym	acetaminophen 325 MG / dextromethorphan hydrobromide 20 MG / guaiFENesin 200 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
NAMES	Tallman Synonym	APAP 325 MG / Dextromethorphan Hydrobromide 20 MG / guaiFENesin 200 MG / Pseudoephedrine Hydrochloride 60 MG Oral Tablet
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