Home NDC 68016-733 Night Time Sinus and Congestion
Product NDC 68016-733
11-digit product format 680160733
Labeler code 68016
Product ID 68016-733_65d6722c-4fef-9dfd-387d-e6f6e2011148
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Doxylamine succinate, Phenylephrine HCl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Chain Drug Consortium, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-10-12
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; 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 · 44 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 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68016-733-16 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68016-733-16 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68016-733-16 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68016-733-16 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68016-733-16 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68016-733-16 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68016-733-16 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68016-733-16 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68016-733-16 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68016-733-16 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68016-733-16 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68016-733-16 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68016-733-16 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68016-733-16 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68016-733-16 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68016-733-16 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68016-733-16 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68016-733-16 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68016-733-16 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…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 68016-733-16 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 68016-733-16 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 68016-733-16 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-733-16 Night Time Sinus and Congestion 8 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 8 1 68016-733-16 Night Time Sinus and Congestion 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-733 NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 Legacy NDC, 2 package rows 20151013_842706f9-eedf-1783-49ed-e6b7ae7d650e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68016-733-16 68016073316 8 in 1 BLISTER PACK Historical