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 44 of 256 · 5,118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLC73c1059b-0c7d-42ef-9827-f018858fc4472026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Multi-Symptom Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companyd0f896a6-5637-45ef-bf60-b343cbcdcf7e2026-04-17WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: 451W47IQ8X
Parry-500mg AcetaminophenACETAMINOPHENMDC PHARMACEUTICALS LIMITEDfb07ba10-3210-41bc-9310-c952118fdcf32026-04-17WarningsExact identifier
unii: 362O9ITL9D
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 451W47IQ8X
Multi-Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companybf3158af-89ab-4b7c-9f39-0f316fbe90562026-04-17WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEFamily Dollar Services Incd9050ed0-455d-4903-8f30-3e9ec9a128862026-04-17WarningsExact identifier
unii: 362O9ITL9D
equate cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.e83d14cc-9b90-40ce-a00a-2702d8a8968f2026-04-17WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEValu Merchandisers Company99de2c41-59b0-42e7-847e-e51229c6164f2026-04-17WarningsExact identifier
unii: 362O9ITL9D
Pain and Fever ChildrensACETAMINOPHENWalgreen Company1f3e2895-5ef7-4e6a-8d2e-b805d148f9802026-04-16WarningsExact identifier
unii: 362O9ITL9D
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCb297aff8-a08b-4d37-b168-800a56564cbd2026-04-16WarningsExact identifier
unii: 362O9ITL9D
Childrens TylenolACETAMINOPHENKenvue Brands LLC9782fe86-d72a-4231-b1ba-d3f3b4ee49e32026-04-16WarningsExact identifier
unii: 362O9ITL9D
Equaline HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa6ed1987-37ad-4bfd-8cea-f03426953f5a2026-04-16WarningsExact identifier
unii: 04JA59TNSJ
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLDOLGENCORP, LLC8e65478b-7a7b-416c-b8e3-23dad79f8cc12026-04-16WarningsExact identifier
unii: 362O9ITL9D
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cold Multi-Symptom SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companyb0d9d869-9f0d-4834-aa2b-1ee21fd8b67b2026-04-16WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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