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 34 of 256 · 5,118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7050b583-c09b-4457-9a9c-70c0923b62c02026-05-19WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC27312ee4-d1f4-4a95-9c45-91fa5a01f5ba2026-05-19WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucinex Rapid Clear Daytime Pain, Headache, and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC37de53a7-5546-3804-e063-6294a90a0fb52026-05-19WarningsExact identifier
unii: 362O9ITL9D
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC36b07e49-c72c-45e5-e063-6394a90a804a2026-05-19WarningsExact identifier
unii: 362O9ITL9D
Mucinex Fast-Max Congestion and Headache Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7017328-f8af-4601-9232-dc1104feaa0a2026-05-19WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucinex Rapid Clear Pain Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC32375b12-75ed-d605-e063-6294a90ad0042026-05-19WarningsExact identifier
unii: 362O9ITL9D
Mucinex Sinus-Max Pressure, Pain and Cough Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC07da45b5-d05e-41b1-b233-f7034d556a8d2026-05-19WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucinex Sinus-Max Severe Congestion and Pain Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCad4e0e4d-cc1f-4176-835f-3ba76564c6342026-05-19WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucinex Childrens Mini Melts Cold and FluACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC401fe0a0-ec97-5248-e063-6394a90af27f2026-05-19WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENST. MARY'S MEDICAL PARK PHARMACY3d347b9b-1b5c-68c8-e063-6294a90aaa9b2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATETopco Associates, LLC62f03f3c-8475-40bd-a5e4-ec9292b747852026-05-19WarningsExact identifier
unii: 362O9ITL9D
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
GOOD SENSE DAYTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2597e84c-18b4-41a9-8e6a-ff0c4c1f06122026-05-18WarningsExact identifier
unii: 362O9ITL9D
Childrens Mucus Cough and Congestion ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8b5d391b-6c23-44c3-81d0-c08822bf6d012026-05-18WarningsExact identifier
unii: 04JA59TNSJ
Walgreens Headache Relief Extra StrengthACETAMINOPHEN 250MG, ASPIRIN 250MG AND CAFFEINE 65MGWalgreens52109b65-3bf1-de38-e063-6394a90a97272026-05-18WarningsExact identifier
unii: 362O9ITL9D
Mucinex Childrens Night Time Multi-Symptom ColdACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCe048cd53-a3cd-484f-a972-4cb49791dba32026-05-18WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucinex Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7354f57c-0ecf-481f-9482-0040c90c43502026-05-18WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Childrens Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC5bda415d-739f-4ca5-b5b2-07c14a81863b2026-05-18WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucinex Childrens Multi-Symptom Cold and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8f3eb5c5-832e-4806-b3da-ef112cf55dcf2026-05-18WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucinex Childrens Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd9e5a8d7-814c-4ab1-bb05-e4cb9155978e2026-05-18WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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