FDA.reportPublic FDA data

Acetaminophen, Phenylephrine Hydrochloride, Chlorpheniramine Maleate

Manufacturer
Contract Pharmacal Corp.
Effective date
2020-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:05:07

Label at a glance#

ProductAcetaminophen, Phenylephrine Hydrochloride, Chlorpheniramine Maleate
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure2 sections

Label contents#

Full prescribing information#

Belarus Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Belarus LabelBelarus Label

Ukraine Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ukraine LabelUkraine Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10267-2657-5Acetaminophen, Phenylephrine Hydrochloride, Chlorpheniramine Maleate17000 mg in 1 PACKETPOWDER, FOR SOLUTION170001
10267-2657-5Acetaminophen, Phenylephrine Hydrochloride, Chlorpheniramine Maleate5 in 1 CARTONPOWDER, FOR SOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10267-2657ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE POWDER, FOR SOLUTION [CONTRACT PHARMACAL CORP.]12 package rows20200407_827f9b0a-e4dc-63a3-e053-2991aa0ae0a0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10267-265710267-2657-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C YELLOW NO. 1035SW5USQ3GIACT
SUCROSEC151H8M554IACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
LEMON24RS0A988OIACT
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

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
827f9b0a-e4dd-63a3-e053-2991aa0ae0a0827f9b0a-e4dc-63a3-e053-2991aa0ae0a02020-04-02Exact identifier
spl id: 827f9b0a-e4dd-63a3-e053-2991aa0ae0a0
spl set id: 827f9b0a-e4dc-63a3-e053-2991aa0ae0a0

Reported adverse events (FAERS/openFDA)#

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