Home NDC 63868-369-04 Triacting Daytime Cold Cough
Product NDC 63868-369
Requested package NDC 63868-369-04
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 · 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.
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