FDA.reportPublic FDA data

NOCOLD-F

Manufacturer
Lydia Co., Ltd.
Effective date
2021-11-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:54

Label at a glance#

ProductNOCOLD-F
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMID

OTC - PURPOSE SECTION

First symtoms of a cold(snot, nasal stuffiness, sneeze, throat pain, cough, phlegm, chill, pyrexia, headache, arthralgia, myalgia) alleviate

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

adult and children 16 years and over: take 1 bottle per session 3 times a day after meal

children 11 to 15 years: take 2/3 bottle once a day

children 7 to 10 years: take 1/2 bottle once a day

children 3 to 6 years: take 1/3 bottle once a day

children 2 years: take 1/4 bottle once a day

under 2 years: ask a doctor

WARNINGS SECTION

When using this product
Do not use for a period longer than 1 weeks
Stop use and ask a doctor if nervousness, dizziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days.
fever gets worse or lasts more than 3 days
New symptoms occur
These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children, In case of overdose, get medical help or contact a poison control center right away

INACTIVE INGREDIENT SECTION

SODIUM BENZOATE, CITRIC ACID MONOHYDRATE,
SODIUM CITRATE DIHYDRATE, L-SODIUM GLUTAMATE, SUGAR,
D-SORBITOL SOLUTION, DISTILLED WATER

DOSAGE & ADMINISTRATION SECTION

For oral use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2588212acetaminophen 200 MG / chlorpheniramine maleate 15 MG / dextromethorphan HBr 2.5 MG in 30 mL Oral SolutionPSN1
2588212acetaminophen 6.67 MG/ML / chlorpheniramine maleate 0.0833 MG/ML / dextromethorphan hydrobromide 0.5 MG/ML Oral SolutionSCD1
2588212acetaminophen 200 MG / chlorpheniramine maleate 15 MG / dextromethorphan hydrobromide 2.5 MG per 30 ML Oral SolutionSY1
2588212APAP 6.67 MG/ML / chlorpheniramine maleate 0.0833 MG/ML / dextromethorphan hydrobromide 0.5 MG/ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0027-1NOCOLD-F30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0027NOCOLD-F (ACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [LYDIA CO., LTD. ]1Current NDC, Legacy NDC, 1 package rows20211115_d0b20c56-de2a-1489-e053-2995a90a6a06.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72988-002772988-0027-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB

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
NOCOLD-FACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDELydia Co., Ltd.d0b20c56-de2a-1489-e053-2995a90a6a062021-11-13WarningsExact identifier
ndc (package): 72988-0027-1
ndc (product): 72988-0027
ndc11 (package): 72988002701
spl id: d0b20c56-de2b-1489-e053-2995a90a6a06
spl set id: d0b20c56-de2a-1489-e053-2995a90a6a06

Reported adverse events (FAERS/openFDA)#

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