Home NDC 0067-8106-04 TRIAMINIC
Product NDC 0067-8106
Requested package NDC 0067-8106-04
11-digit product format 000678106
Labeler code 0067
Product ID 0067-8106_893f86bf-9058-4b2f-a703-e25174cda029
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl, 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 DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 6 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 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRIAMINIC NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [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 0067-8106-04 00067810604 118 mL in 1 BOTTLE (0067-8106-04) 118 ml 2012-10-15 0000-00-00 No No Current