FDA.reportPublic FDA data

Theraflu

Product NDC
0067-7917
11-digit product format
000677917
Labeler code
0067
Product ID
0067-7917_1006345e-67d7-8b81-e063-6294a90ad7cd
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-24
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Theraflu
Brand name suffix
Daytime Severe Cold and Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659967Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0689223-5c90-4dbc-bbfa-f94e267504c3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-7917-06TherafluDaytime Severe Cold and Cough1 in 1 PACKETPOWDER, FOR SOLUTION18
0067-7917-06TherafluDaytime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-7917-06EA - Each0067-7917a93e7ffe-37c0-43d7-b368-02efbb23b37612016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTHERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
SUCROSEINACTIVE INGREDIENTC151H8M554THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-7917THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 2 package rows20240129_c0689223-5c90-4dbc-bbfa-f94e267504c3.zip

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 36 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Panadol Cold and Flu NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3417993d-8e3c-23d6-e063-6394a90a7d502026-04-29WarningsExact identifier
application number: M012
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC509f233e-ff01-8927-e063-6394a90a99292026-04-29WarningsExact identifier
application number: M012
Broncomiel AdultsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509c61d3-ae16-be5c-e063-6294a90a68da2026-04-29WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINTOP CARE (Topco Associates LLC)aa1eb90c-e565-455f-8978-6f2f9e00a8142026-04-29WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DM adultDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLCe1280355-da81-489f-9bd2-ffea9a68010c2026-04-29WarningsExact identifier
application number: M012
Mucus Relief ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC7b095ec5-9951-4491-9b68-7ac0a7f100532026-04-29WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOP CARE (Topco Associates LLC)98dd0ba6-0109-46b2-92df-11a0309842402026-04-28WarningsExact identifier
application number: M012
Pain, Headache and CongestionACETAMINOPHEN, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED41a77cbb-6a4d-46a4-ab27-c7affa2cc6822026-04-28WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.dd7da15a-4e0b-405f-e053-2995a90a06d22026-04-28WarningsExact identifier
application number: M012
CAREONE CHILDRENS COLD COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDERetail Business Services, LLC382f7d51-ceb8-4bdf-9bd5-440b50c65cd32026-04-28WarningsExact identifier
application number: M012
Cold and Flu Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.1a520b4f-6a4b-4e37-94c5-9387f2e4c34a2026-04-27WarningsExact identifier
application number: M012
Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKroger49a7cd2a-8c0e-2196-e063-6294a90a134a2026-04-27WarningsExact identifier
application number: M012
Guaifenesin,Dextromethorphan HbrGUAIFENESIN,DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd3e5d978f-cc70-60a5-e063-6394a90a67d32026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd36ced59c-12dc-441f-e063-6294a90a32392026-04-27WarningsExact identifier
application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLSoftgel Healthcare Private Limited30ab39f3-27cc-5728-e063-6394a90a9cbe2026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited353f71f7-81e0-08c2-e063-6294a90acb492026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr ,GuaifenesinACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESINSoftgel Healthcare Pvt Ltd353ef34f-760d-ae92-e063-6294a90a5b4a2026-04-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0203d919-dc1f-cca0-e063-6394a90aa1aa2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.507214ad-1e06-fe21-e063-6294a90a59cd2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50738a43-7299-270c-e063-6294a90af2cc2026-04-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNc0689223-5c90-4dbc-bbfa-f94e267504c38
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDc0689223-5c90-4dbc-bbfa-f94e267504c38
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSYc0689223-5c90-4dbc-bbfa-f94e267504c38
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYc0689223-5c90-4dbc-bbfa-f94e267504c38
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN60acfcf4-5b55-40ef-b432-faeed84578811
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD60acfcf4-5b55-40ef-b432-faeed84578811
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSY60acfcf4-5b55-40ef-b432-faeed84578811
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY60acfcf4-5b55-40ef-b432-faeed84578811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-7917-06000677917066 PACKET in 1 CARTON (0067-7917-06) / 1 POWDER, FOR SOLUTION in 1 PACKET6 packet2012-09-240000-00-00NoNoCurrent