Home NDC 0067-8124 Theraflu Nighttime Multi-Symptom Severe Cold Powder
Product NDC 0067-8124
11-digit product format 000678124
Labeler code 0067
Product ID 0067-8124_16be0a08-f1de-4da9-a689-c1e71bde4926
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Dosage form POWDER
Route ORAL
Labeler GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-07-15
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 500 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0067-8124-06 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0067-8124-06 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0067-8124-06 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0067-8124-06 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0067-8124-06 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0067-8124-06 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0067-8124-06 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0067-8124-06 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0067-8124-06 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0067-8124-06 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0067-8124-06 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0067-8124-06 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [NOVARTIS CONSUMER HEALTH, INC.] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0067-8124-06 00067812406 6 POWDER in 1 CARTON (0067-8124-06) 6 powder 2015-07-15 0000-00-00 No No Current