Home NDC 68016-630 DAYTIME SINUS AND CONGESTION
Product NDC 68016-630
11-digit product format 680160630
Labeler code 68016
Product ID 68016-630_2f2ffcae-88c0-67ef-8982-9702ef531a0c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Chain Drug Consortium, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-10-13
Marketing end 0000-00-00
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1
NDC exclude flag E
Listing certified through 2018-12-31
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 · 28 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 68016-630-16 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 68016-630-16 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 68016-630-16 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 68016-630-16 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 68016-630-16 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 68016-630-16 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 68016-630-16 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 68016-630-16 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 68016-630-16 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68016-630-16 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68016-630-16 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68016-630-16 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…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 68016-630-16 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68016-630-16 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DAYTIME SINUS AND CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1