Home NDC 68016-706-12 COLD and FLU Day Time Multi-Symptom Relief
Product NDC 68016-706
Requested package NDC 68016-706-12
11-digit product format 680160706
Labeler code 68016
Product ID 68016-706_b11be7a0-6625-4af7-b37f-d23d0b96a012
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine HCl, and Dextromethorphan HBr
Dosage form SOLUTION
Route ORAL
Labeler Chain Drug Consortium, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-07-27
Marketing end 2021-09-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/15mL; mg/15mL; mg/15mL
NDC exclude flag No
Listing certified through 0000-00-00
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 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 ORANGE INACTIVE INGREDIENT 5EVU04N5QU COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SACCHARIN SODIUM ANHYDROUS INACTIVE INGREDIENT I4807BK602 COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-706-12 68016070612 354 mL in 1 BOTTLE (68016-706-12) 354 ml 2015-07-27 2021-09-01 No No Current