Home NDC 63868-369 Triacting Daytime Cold Cough
Product NDC 63868-369
11-digit product format 638680369
Labeler code 63868
Product ID 63868-369_39d8e03f-50ad-4258-80a5-e101ec1e783b
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Phenylephrine HCl
Dosage form SYRUP
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-05-30
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5 mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2020-12-31
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 63868-369-04 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 63868-369-04 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 63868-369-04 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 63868-369-04 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 63868-369-04 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 63868-369-04 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 63868-369-04 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 63868-369-04 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 63868-369-04 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 63868-369-04 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 63868-369-04 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 63868-369-04 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 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 MALTITOL INACTIVE INGREDIENT D65DG142WK TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 WATER INACTIVE INGREDIENT 059QF0KO0R TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63868-369-04 63868036904 1 BOTTLE, PLASTIC in 1 BOX (63868-369-04) > 118 mL in 1 BOTTLE, PLASTIC 2014-05-30 0000-00-00 No No Current