FDA.reportPublic FDA data

NDC 0067-7916-01 - Theraflu Flu and Sore Throat

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0067-7916
Requested NDC
0067-7916-01
Package NDCs from labels
0067-7916-01, 0067-7916-06
Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date
2020-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACETAMINOPHEN - GlaxoSmithKline Consumer Healthcare Holdings (US) LLCGlaxoSmithKline Consumer Healthcare Holdings (US) LLC2020-08-14HUMAN OTC DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-7916-06EA - Each0067-7916cdf4b20d-293a-49ae-8f78-b43bfb3090a012014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
PHENIRAMINE MALEATEACTIVE INGREDIENTNYW905655BTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
PHENIRAMINEACTIVE MOIETY134FM9ZZ6MTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTHERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]3

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 14 of 262 · 5,226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEKroger Companye97383af-6fbe-4531-af6a-c9ea9153e4382026-08-03WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-08-03WarningsExact identifier
unii: 362O9ITL9D
Tukol Max Action Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAcf0987a3-2c1d-4f40-8551-df9a8e08cd3d2026-08-03WarningsExact identifier
unii: 362O9ITL9D
Pressure, Pain and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.7d42e164-86e9-4baa-a389-3271cf99920e2026-08-03WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Stona for ChildrenACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.18f3d694-9dff-407e-a264-916dbd201f9a2026-07-31WarningsExact identifier
unii: 362O9ITL9D
StonarhiniCHLORPHENIRAMINE MALEATE, PHENYLEPHRINESato Pharmaceutical Co., Ltd.cc353280-0b4c-418c-93fe-8501259550092026-07-31WarningsExact identifier
unii: 04JA59TNSJ
cold and flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEMeijer Distribution Inc5519e918-71cb-4430-ae57-e03cd5ac60022026-07-31WarningsExact identifier
unii: 362O9ITL9D
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 91D9GV0Z28
unii: 451W47IQ8X
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens Pain and FeverACETAMINOPHENAurohealth LLCd4e98f8e-f24c-4bdd-b750-fa4f877fb6212026-07-31WarningsExact identifier
unii: 362O9ITL9D
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLC1767c4b7-36a0-4e64-9091-2af22161402f2026-07-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
unii: 362O9ITL9D
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLCf43e4abd-0083-4fe5-9c27-0ba9245e51382026-07-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLC53f7a9c8-f40e-19b2-e063-6394a90a86952026-07-29WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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