Home NDC 68016-221 Severe Congestion and Cough MAX
Product NDC 68016-221
11-digit product format 680160221
Labeler code 68016
Product ID 68016-221_b7e3be25-e9ce-4568-8459-c2c7caffe68c
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form LIQUID
Route ORAL
Labeler Chain Drug Consortium, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-01-01
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 20 mg/20mL; mg/20mL; mg/20mL
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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68016-221-00 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68016-221-00 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68016-221-00 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68016-221-00 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68016-221-00 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68016-221-00 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68016-221-00 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68016-221-00 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68016-221-00 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68016-221-00 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68016-221-00 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [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 68016-221-00 68016022100 177 mL in 1 BOTTLE (68016-221-00) 177 ml 2013-01-01 0000-00-00 No No Current