Home NDC 0067-6801 Theraflu Severe Cold relief Nighttime
Product NDC 0067-6801
11-digit product format 000676801
Labeler code 0067
Product ID 0067-6801_132cdb61-2615-2863-e063-6394a90a7e5a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Dosage form POWDER
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-20
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 500; 25; 10 mg/1; mg/1; mg/1
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 Severe Cold relief Nighttime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 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 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 1659175 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 0067-6801-02 Theraflu Severe Cold relief Nighttime 6 in 1 CARTON POWDER 6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-6801 THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [HALEON US HOLDINGS LLC] 2 Current NDC, 1 package rows 20240310_0d3b1bea-e2ca-4e07-8ae5-60627d230c96.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 Sample Exclude flag Status 0067-6801-02 00067680102 6 POWDER in 1 CARTON (0067-6801-02) 6 powder 2022-01-20 No No Current