Home NDC 0067-7916-06 Theraflu
Product NDC 0067-7916
Requested package NDC 0067-7916-06
11-digit product format 000677916
Labeler code 0067
Product ID 0067-7916_d8ddbe3f-aaa9-46a9-a96f-11670daec9ac
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Pheniramine Maleate, Phenylephrine HCl
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-05-13
Marketing end 0000-00-00
Substance ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 PHENIRAMINE MALEATE ACTIVE INGREDIENT NYW905655B THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 PHENIRAMINE ACTIVE MOIETY 134FM9ZZ6M THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.] 3 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 THERAFLU FLU AND SORE THROAT (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [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 0067-7916-06 00067791606 6 PACKET in 1 CARTON (0067-7916-06) > 1 POWDER, FOR SOLUTION in 1 PACKET (0067-7916-01) 6 packet 2005-05-13 0000-00-00 No No Current