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 47 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GOOD REMEDIES Extra Strength Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d642d8e-c154-a970-e063-6294a90a03bf 2025-03-14 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4 2025-03-07 Warnings Exact identifier application number: M013 Redicare Non-Aspirin 500mg REDICARE NON-ASPIRIN, ACETAMINOPHEN 500MG Redicare LLC 2f229898-1777-732c-e063-6394a90a76bc 2025-03-04 Warnings, Adverse reactions Exact identifier application number: M013 Major Extra Strength Acetaminophen Liquid ACETAMINOPHEN Major Pharmaceuticals 2f3af4dd-45d5-87b4-e063-6294a90ab3cc 2025-02-28 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs ed9a71d6-a56e-416a-bb89-6d41307efc5a 2025-02-27 Warnings Exact identifier application number: M013 Aspirin ASPIRIN PD-Rx Pharmaceuticals, Inc. 77429b7f-78e4-42c0-8679-ae8da1748848 2025-02-26 Warnings Exact identifier application number: M013 AeroTab Non-Aspirin ACETAMINOPHEN 500MG ES Aero Healthcare faa3a4ef-3c70-06ca-e053-6394a90a512d 2025-02-26 Warnings Exact identifier application number: M013 Bufferin Regular Strength Pain Relief ASPIRIN Genomma Lab USA 3543b2bf-1062-468a-a5dc-eabb2408af8c 2025-02-25 Warnings Exact identifier application number: M013 Calmour Childrens Acetaminophen Strips Chewable ACETAMINOPHEN ORAL CHEWABLE 80 MG Calmour ae47b027-4f29-45bb-a8bd-812978932835 2025-02-22 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC f9de7c2f-016b-4f40-8b5e-141ad194be97 2025-02-20 Warnings Exact identifier application number: M013 Genexa Acetaminophen PM Extra Strength ACETAMINOPHEN Genexa Inc. d82cf6f3-a291-ca2b-e053-2a95a90a6de1 2025-02-20 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Advagen Pharma Limited 8b9456c9-a56b-4748-adb8-c66d6bf072e8 2025-02-19 Warnings Exact identifier application number: M013 Genexa Childrens Acetaminophen ACETAMINOPHEN Genexa Inc. d89fd9d8-d88e-3968-e053-2a95a90afc5f 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. debfa787-7a48-48b5-94b0-612820524032 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. b16e5dcf-b290-4ff2-a150-4b875647ec9a 2025-02-19 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC bb6533e5-e6a9-488c-b8ab-a6a06e87ede9 2025-02-18 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC c830320e-72ba-48ff-a4cd-250ac5650bf0 2025-02-18 Warnings Exact identifier application number: M013 Aspirina Caplets ASPIRIN Bayer HealthCare LLC. 2e6f5ba8-8e8b-6059-e063-6394a90adcd5 2025-02-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. da7d95af-6583-429d-8d04-e0424f32e9ad 2025-02-17 Warnings Exact identifier application number: M013 GOODYS Mental Alert ASPIRIN AND CAFFEINE Medtech Products Inc. 31ef6d07-d314-4d09-abcd-389ba66cbcc5 2025-02-17 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