Home NDC 68016-154 Night Time Severe Cold and Cough Relief
Product NDC 68016-154
11-digit product format 680160154
Labeler code 68016
Product ID 68016-154_2f8462e8-7096-4688-ba3d-14caae022944
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
Dosage form LIQUID
Route ORAL
Labeler Chain Drug Consortium, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-10-04
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 10 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 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 68016-154-08 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 68016-154-08 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 68016-154-08 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…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 68016-154-08 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 68016-154-08 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Night Time Severe Cold and Cough Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/15mL DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/15mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1298348 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 68016-154-08 Night Time Severe Cold and Cough Relief 245 mL in 1 BOTTLE LIQUID 245 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-154 NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20241231_c8e9b57b-83e9-46c5-9791-02c4c2b94004.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 23 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin 81 mg ASPIRIN HYVEE INC 3e602287-565e-a5b9-e063-6294a90abc17 2026-01-13 Warnings Exact identifier application number: M013 ASPIRIN DELAYED RELEASE 81MG ASPIRIN DELAYED RELEASE 81MG Farmacias De Similares TX LLC 3a8a3efc-f0b3-411c-e063-6394a90a84b7 2026-01-13 Warnings Exact identifier application number: M013 Chewable Aspirin 81 mg ASPIRIN HYVEE INC 459f749f-9d23-8752-e063-6394a90a8c81 2026-01-13 Warnings Exact identifier application number: M013 ASPIRIN 325 mg ASPIRIN HYVEE INC 459d01df-6ff6-cff6-e063-6394a90ab35c 2026-01-13 Warnings Exact identifier application number: M013 Pain Terminator Extra Strength Pain Relief CAFFEINE, ACETAMINOPHEN, ASPIRIN Wildman Business Group 8ffb02d9-92df-4d2f-a367-1c71490807fb 2026-01-12 Warnings Exact identifier application number: M013 Aspirin Packs ASPIRIN Sina Health Inc 2865a2c3-53fc-ab9a-e063-6394a90a1418 2026-01-12 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 64696f65-415e-4ce1-a5b3-70662fbcb002 2026-01-12 Warnings Exact identifier application number: M013 Aspirin enteric coated low dose ASPIRIN Walgreen Company 186a6270-e3de-4499-88a4-5f723fee3e34 2026-01-12 Warnings Exact identifier application number: M013 Tension Headache ACETAMINOPHEN, CAFFEINE Cardinal Health 110, LLC. DBA Leader 96684e3f-a13e-49c3-b437-d2627e528a2d 2026-01-12 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Family Dollar Services Inc d35d798e-76f1-454d-86f6-ad11c3bf17d8 2026-01-12 Warnings Exact identifier application number: M013 Xpect Acetaminophen ACETAMINOPHEN Cintas Corporation f4aed854-730e-493d-b523-122156e08dde 2026-01-09 Warnings Exact identifier application number: M013 Aspirin ASPIRIN INVAHEALTH INC e5e8a8d5-9174-7975-e053-2a95a90a9aa6 2026-01-08 Warnings Exact identifier application number: M013 Xpect Cold Relief ACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCL Cintas Corporation 02391d55-32b2-4083-9315-98e9b3650c55 2026-01-08 Warnings Exact identifier application number: M013 pain relief back and body EXTRA STRENGTH ASPIRIN, CAFFEINE Rite Aid Corporation a71392c8-3f5b-4d00-baba-a4055ed68bc1 2026-01-07 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN L.N.K. International, Inc. 8fed703a-9de2-4c76-a783-fcf004f9b890 2026-01-07 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Amerisource Bergen c3099892-a8cd-4574-a6f9-041e59e2feae 2026-01-07 Warnings Exact identifier application number: M013 Bactimicina Childrens Pain and Fever ACETAMINOPHEN DLC Laboratories, Inc. bdade270-d813-4178-b594-4951632b6839 2026-01-07 Warnings Exact identifier application number: M013 Goodmeds Extra Strength Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Cabinet Health P.B.C. 02c60967-46d7-49b7-82be-bc3c5fd36484 2026-01-06 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN ARMY AND AIR FORCE EXCHANGE SERVICE a73f8217-9eae-4e2a-b29c-7de3861d0e37 2026-01-06 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen PM ACETAMINOPHEN AND DIPHENHYDRAMINE HCL Rite Aid Corporation f77f0120-4042-4b11-ba9c-cd35e1cd0bee 2026-01-05 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-154-08 68016015408 245 mL in 1 BOTTLE (68016-154-08) 245 ml 2013-10-04 0000-00-00 No No Current