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 2026-12-31
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 5 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SurviveX Travel Med MOD CONVENIENCE KIT Intent Brands LLC 522da86b-cfd7-dd20-e063-6394a90a51c6 2026-08-04 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever mini softgels ACETAMINOPHEN 500 MG Shield Pharmaceuticals Corp 0ebb1902-6f8a-4bfb-9f2e-839d43bfca37 2026-08-04 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Better Living Brands, LLC 743af02c-c762-42f5-8e01-2f62da15e04e 2026-08-04 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC 9aea8aae-8702-4c93-8b07-69cd252f44d6 2026-08-03 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen 325 mg ACETAMINOPHEN NUVICARE LLC 49a59b79-b8b4-4bf5-a403-0a14751efc55 2026-08-03 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC d4e98f8e-f24c-4bdd-b750-fa4f877fb621 2026-07-31 Warnings Exact identifier application number: M013 KinderFarms Childrens Pain and Fever ACETAMINOPHEN KinderFarms, LLC 4f86419a-b940-a9c6-e063-6394a90a6a2b 2026-07-30 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Family Dollar Stores, LLC 53f7a9c8-f40e-19b2-e063-6394a90a8695 2026-07-29 Warnings Exact identifier application number: M013 KinderFarms Infants Pain and Fever ACETAMINOPHEN KinderFarms, LLC 5468b149-8fac-8d6a-e063-6294a90a8c51 2026-07-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS PHARMACY 258975d2-d8e8-407d-9804-df3b37a184e4 2026-07-29 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 3ba0a9f2-062a-401e-82eb-54383a822366 2026-07-29 Warnings Exact identifier application number: M013 Aspirin 81mg Enteric Coated ASPIRIN Cardinal Health 107, LLC 277723db-3578-4842-92eb-2de325f87649 2026-07-28 Warnings Exact identifier application number: M013 Aspirin Low Dose Chewable ASPIRIN Better Living Brands, LLC 7afce7b4-c86a-43f7-83cf-15ebffba2f35 2026-07-28 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC f818996c-36d2-4d3d-af3e-39949157edb9 2026-07-28 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L.N.K. International, Inc. 03b871e8-3e14-4ed8-a978-45129255b272 2026-07-27 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HCL Rite Aid Corporation 17d27771-a112-474f-9a58-29af0d7e1af3 2026-07-27 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC 2143cc16-86db-4060-96da-5c228ae9207b 2026-07-24 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Softgel Healthcare Pvt Ltd 352bb451-ffdc-411a-e063-6294a90a8cf5 2026-07-24 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN NuCare Pharmaceuticals,Inc. fdb7331a-d029-8b2a-e053-6294a90adfcd 2026-07-24 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC 5ada044e-50e8-4874-ac04-df5f1f9e735d 2026-07-24 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