Home NDC 0067-7918 THERAFLU
Product NDC 0067-7918
11-digit product format 000677918
Labeler code 0067
Product ID 0067-7918_100acde5-89b2-0bed-e063-6294a90aa1a9
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DIPHENHYDRAMINE HCL, 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; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 25; 10 mg/237mL; mg/237mL; mg/237mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 NIGHTTIME SEVERE COLD AND COUGH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/237mL DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/237mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/237mL
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 TC2D6JAD40 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 1659960 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 0067-7918-01 THERAFLUNIGHTTIME SEVERE COLD AND COUGH 237 mL in 1 PACKET POWDER, FOR SOLUTION 237 12 0067-7918-06 THERAFLUNIGHTTIME SEVERE COLD AND COUGH 6 in 1 CARTON POWDER, FOR SOLUTION 6 12 0067-7918-01 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough 237 mL in 1 PACKET POWDER, FOR SOLUTION 1422 mL 650 mg in 237mL 8 0067-7918-01 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough 237 mL in 1 PACKET POWDER, FOR SOLUTION 1422 mL 650 mg in 237mL 8 0067-7918-06 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough 6 in 1 CARTON POWDER, FOR SOLUTION 650 mg in 237mL 8 0067-7918-06 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough 6 in 1 CARTON POWDER, FOR SOLUTION 650 mg in 237mL 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-7918 THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] 12 Current NDC, Legacy NDC, 2 package rows 20240129_5f7f6f70-0f36-4541-89f2-d953259cdb1e.zip 0067-7918 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
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 71 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CAREALL Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc f3b177ef-55d5-4525-bf33-99205c414a5b 2025-12-22 Warnings Exact identifier application number: M012 CAREALL Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc af2f8389-d696-4060-8abd-6eda04e73009 2025-12-22 Warnings Exact identifier application number: M012 BASIC CARE DAYTIME NIGHTTIME SEVERE COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Amazon.com Services LLC 82e68c65-9898-4106-a2f8-e39d124c703e 2025-12-22 Warnings Exact identifier application number: M012 Nighttime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Harris Teeter, LLC 89fd57d2-fe49-41cb-b02e-9643e526cf47 2025-12-22 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Walgreens 464f6645-ca33-1722-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Walgreen Co. 47f38e79-c730-21b9-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Walgreen Co. 47522852-005a-2a66-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon Cough Drop MENTHOL Walgreens Co, 47653657-80b5-482f-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon Cough Drop MENTHOL Walgreen Co. 47f89d33-6e0a-4bb4-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Strawberry Cough Drop MENTHOL 2.7 MG Walgreen Co. 4766afa8-fdaf-05e5-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 SF Menthol Cough Drop MENTHOL Walgreen Co. 477b9fc3-c3c5-647e-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 SF Honey Lemon Cough Drop MENTHOL Walgreen Co. 477cedee-6bd3-2a34-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE Walgreens Co. 47e0f809-0b30-2b23-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Sugar Free Honey Lemon Cough Drops MENTHOL Walgreen 835e276a-493e-1038-e053-2a91aa0a7ea2 2025-12-21 Warnings Exact identifier application number: M012 Walgreens Mixed Berry Benz-Dex Lozenges BENZOCAINE Walgreen e108731f-6b77-225a-e053-2a95a90ac25c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Walmart Stores Inc. 318e7acb-0ebb-4518-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Walmart Stores Inc. 316968e1-7715-4caa-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon cough drops MENTHOL Walmart Stores Inc. 317bbd33-6087-3af1-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012
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 0067-7918-01 00067791801 237 mL in 1 PACKET 237 ml Historical 0067-7918-06 00067791806 6 PACKET in 1 CARTON (0067-7918-06) / 237 mL in 1 PACKET (0067-7918-01) 6 packet 2014-07-01 0000-00-00 No No Current