Home NDC 0067-8105-04 Triaminic
Product NDC 0067-8105
Requested package NDC 0067-8105-04
11-digit product format 000678105
Labeler code 0067
Product ID 0067-8105_a7817767-c6af-459c-b807-8a7aac951dea
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Phenylephrine HCl
Dosage form SYRUP
Route ORAL
Labeler GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-10-15
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5 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 · 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 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 CHERRY INACTIVE INGREDIENT BUC5I9595W TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0067-8105-04 00067810504 1 BOTTLE, PLASTIC in 1 CARTON (0067-8105-04) > 118 mL in 1 BOTTLE, PLASTIC 2012-10-15 0000-00-00 No No Current