Home NDC 0067-8116 Triaminic
Product NDC 0067-8116
11-digit product format 000678116
Labeler code 0067
Product ID 0067-8116_e26aeeb9-84ec-4809-837b-fdadd8649585
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form SUSPENSION
Route ORAL
Labeler GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-09-30
Marketing end 0000-00-00
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 160 mg/5mL; mg/5mL; mg/5mL; mg/5mL
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 · 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 0067-8116-04 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 0067-8116-04 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 0067-8116-04 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 0067-8116-04 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 0067-8116-04 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 0067-8116-04 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 0067-8116-04 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 0067-8116-04 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 0067-8116-04 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 0067-8116-04 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 0067-8116-04 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 0067-8116-04 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 TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 CALCIUM SULFATE INACTIVE INGREDIENT WAT0DDB505 TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 SODIUM PHOSPHATE, TRIBASIC INACTIVE INGREDIENT A752Q30A6X TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [NOVARTIS CONSUMER HEALTH, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0067-8116-04 00067811604 1 BOTTLE in 1 CARTON (0067-8116-04) > 118 mL in 1 BOTTLE 1 bottle 2013-09-30 0000-00-00 No No Current