Home NDC 0067-6426 THERAFLU
Product NDC 0067-6426
11-digit product format 000676426
Labeler code 0067
Product ID 0067-6426_100acde5-899f-0bed-e063-6294a90aa1a9
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-07-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 500; 20; 10 mg/237mL; mg/237mL; mg/237mL
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 Additional Listing Data#
Finished product Yes
Brand name base THERAFLU
Brand name suffix MULTI-SYMPTOM SEVERE COLD
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/237mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/237mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/237mL
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ Rxcui 1189316
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0067-6426-01 THERAFLUMULTI-SYMPTOM SEVERE COLD 237 mL in 1 PACKET POWDER, FOR SOLUTION 237 11 0067-6426-06 THERAFLUMULTI-SYMPTOM SEVERE COLD 6 in 1 CARTON POWDER, FOR SOLUTION 6 11 0067-6426-01 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough 237 mL in 1 PACKET POWDER, FOR SOLUTION 1422 mL 500 mg in 237mL 8 0067-6426-01 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough 237 mL in 1 PACKET POWDER, FOR SOLUTION 4266 mL 500 mg in 237mL 8 0067-6426-06 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough 6 in 1 CARTON POWDER, FOR SOLUTION 500 mg in 237mL 8 0067-6426-06 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough 6 in 1 CARTON POWDER, FOR SOLUTION 500 mg in 237mL 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-6426 THERAFLU MULTI-SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] 11 Current NDC, Legacy NDC, 2 package rows 20240129_a4c56ca0-7785-404b-996d-137cc135f270.zip 0067-6426 THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] 8 Current NDC, Legacy NDC 20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip
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 0067-6426-01 00067642601 237 mL in 1 PACKET 237 ml Historical 0067-6426-06 00067642606 6 PACKET in 1 CARTON (0067-6426-06) / 237 mL in 1 PACKET (0067-6426-01) 6 packet 2014-07-01 0000-00-00 No No Current