Home NDC 0067-7917 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 Ingredient Strength ACETAMINOPHEN 650 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1659967 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0067-7917-06 TherafluDaytime Severe Cold and Cough 1 in 1 PACKET POWDER, FOR SOLUTION 1 8 0067-7917-06 TherafluDaytime Severe Cold and Cough 6 in 1 CARTON POWDER, FOR SOLUTION 6 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 1 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 THERAFLU 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 NDC Dashboard title SPL version Validation Dashboard ZIP 0067-7917 THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] 8 Current NDC, Legacy NDC, 2 package rows 20240129_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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0067-7917-06 00067791706 6 PACKET in 1 CARTON (0067-7917-06) / 1 POWDER, FOR SOLUTION in 1 PACKET 6 packet 2012-09-24 0000-00-00 No No Current