Home NDC 0363-0714 Extra Strength NiteTime Pain Relief
Product NDC 0363-0714
11-digit product format 003630714
Labeler code 0363
Product ID 0363-0714_3ac05a52-7cce-2bfb-e063-6394a90a134b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 500 mg,Diphenhydramine Hydrochloride 25 mg Tablet
Dosage form TABLET
Route ORAL
Labeler WALGREENS
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-10-12
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 25; 500 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0363-0714-42 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0363-0714-42 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-0714-42 0efc9e666f02…f202fb6c5f17…
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 Extra Strength NiteTime Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 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 0363-0714-42 Extra Strength NiteTime Pain Relief 24 in 1 BOTTLE TABLET 24 5 0363-0714-42 Extra Strength NiteTime Pain Relief 1 in 1 CARTON TABLET 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0714 EXTRA STRENGTH NITETIME PAIN RELIEF (ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLET) TABLET [WALGREENS] 4 Current NDC, Legacy NDC, 2 package rows 20250210_c25c75c7-157f-1c0d-e053-2995a90a2e3c.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 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Aspirin 81 mg ASPIRIN Asclemed USA, Inc. 878dab20-668b-4d7a-a5f8-794a587564d5 2025-02-13 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN CVS HEALTH CORP bbc48c9e-7eb8-2c67-e053-2a95a90a8552 2025-02-13 Warnings Exact identifier application number: M013 Dye Free Infants Pain and Fever ACETAMINOPHEN CVS 1fde0f7c-4b5b-ae9c-e063-6394a90afa41 2025-02-13 Warnings Exact identifier application number: M013 NOTTS - Extra Strength 500 mg ACETAMINOPHEN VIVUNT PHARMA LLC e677f43d-b4ce-e5b0-e053-2a95a90ad67e 2025-02-12 Warnings Exact identifier application number: M013 Acetaminophen, Aspirin, Caffeine ACETAMINOPHEN, ASPIRIN, CAFFEINE LEADER/ Cardinal Health 110, Inc. b3773f02-02a9-33c8-e053-2995a90a2235 2025-02-11 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN TIME CAP LABORATORIES, INC. c9f80d24-bd05-e1ce-e053-2995a90aa646 2025-02-10 Warnings Exact identifier application number: M013 Low dose Aspirin ASPIRIN 81 MG DELAYED RELEASE TABLETS WALGREENS c25c55aa-9932-0a55-e053-2a95a90a3d1e 2025-02-10 Warnings Exact identifier application number: M013 AeroTab Pain Reliever PAIN RELIEVER Aero Healthcare 40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f 2025-02-10 Warnings Exact identifier application number: M013 Enteric Coated Aspirin Regular Strength ASPIRIN Time-Cap Labs, Inc 5fbd8bb3-46f9-4089-9a21-b6af97a06106 2025-02-08 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN TIME CAP LABS INC c193dbc0-cc80-4a7c-aa29-457a20edf835 2025-02-08 Warnings Exact identifier application number: M013 Daytime Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HBR Genexa Inc. 22f23aeb-f874-6e54-e063-6394a90a9565 2025-02-07 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN BETTER LIVING BRANDS LLC. f3008928-c555-64ad-e053-2995a90a7307 2025-02-05 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN BETTER LIVING BRANDS LLC. f300dfbc-7137-79d1-e053-2995a90a636e 2025-02-05 Warnings Exact identifier application number: M013 Low dose aspirin 81mg ASPIRIN BETTER LIVING BRANDS LLC. f300c30b-ab1a-a1b4-e053-2a95a90a1294 2025-02-05 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 5d174187-cf89-41ff-9a64-10e0276daf17 2025-02-05 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 0363-0714-42 00363071442 1 BOTTLE in 1 CARTON (0363-0714-42) / 24 TABLET in 1 BOTTLE 1 bottle 2021-10-12 0000-00-00 No No Current