Home NDC 11868-466 Cold Preparation
Product NDC 11868-466
11-digit product format 118680466
Labeler code 11868
Product ID 11868-466_58cc3e36-c26c-49ed-b0bc-344ca2926ac4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler New Genesis/Monticello Drug LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-06-30
Marketing end 2021-12-30
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 WATER INACTIVE INGREDIENT 059QF0KO0R COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE COLD PREPARATION FOR COUGH AND SINUS RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MONTICELLO DRUG LLC (NEW GENESIS)] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11868-466-08 11868046608 236 mL in 1 BOTTLE, PLASTIC (11868-466-08) 236 ml 2015-06-30 2021-12-30 No No Current 11868-466-12 11868046612 355 mL in 1 BOTTLE, PLASTIC (11868-466-12) 355 ml 2015-06-30 2021-12-30 No No Current