Home NDC 0067-7919 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough
Product NDC 0067-7919
11-digit product format 000677919
Labeler code 0067
Product ID 0067-7919_15bf1214-572a-f6b6-e063-6394a90ab0cb
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl
Dosage form KIT
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-01
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 Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1189316 Internal RxNorm lookup 1659960 Internal RxNorm lookup 2640034 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 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 0067-6426-06 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough 6 in 1 CARTON POWDER, FOR SOLUTION 500 mg in 237mL 8 0067-7918-01 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 0067-7919-12 Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough 1 in 1 PACKAGE, COMBINATION KIT 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-7919 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, 5 package rows 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 174 of 174 · 3,464 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE Westminster Pharmaceuticals, LLC a58bfb14-28f9-4425-a5a5-aaff4847c979 2018-03-14 Warnings Exact identifier application number: M012 Chlorpheniramine maleate 4mg CHLORPHENIRAMINE MALEATE 4MG Athlete's Needs, Inc. 4d974959-25fc-4707-9b72-9afbf47b76f1 2017-11-14 Warnings Exact identifier application number: M012 Cold Medicine ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL Selder, S.A. de C.V. d2762d9c-e7e7-42b2-a26a-14b2aa0307cb 2017-01-25 Warnings Exact identifier application number: M012 Allergy CHLORPHENIRAMINE MALEATE Marc Glassman, Inc. 2051247f-ce64-4cf5-b449-9ca14c43ab86 2016-12-27 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 0067-6426-01 00067642601 237 mL in 1 PACKET 237 ml Historical 0067-6426-06 00067642606 6 in 1 CARTON Historical 0067-7918-01 00067791801 237 mL in 1 PACKET 237 ml Historical 0067-7918-06 00067791806 6 in 1 CARTON Historical 0067-7919-12 00067791912 1 KIT in 1 PACKAGE, COMBINATION (0067-7919-12) * 6 PACKET in 1 CARTON (0067-6426-06) / 237 mL in 1 PACKET (0067-6426-01) * 6 PACKET in 1 CARTON (0067-7918-06) / 237 mL in 1 PACKET (0067-7918-01) 1 kit 2016-01-01 0000-00-00 No No Current