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 52 of 79 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join acetaminophen ACETAMINOPHEN UNFI e689c9e3-dd4d-c646-e053-2a95a90a4b6a 2024-12-09 Warnings Exact identifier application number: M013 DrKids Childrens Pain and Fever ACETAMINOPHEN 80MG/PIECE CalmCo LLC ff4b0528-39a0-80d5-e053-6394a90a8a83 2024-12-07 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 2024-12-05 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN DISCOUNT DRUG MART e6feff0a-3347-194d-e053-2a95a90acd20 2024-12-05 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN DISCOUNT DRUG MART e6fee238-0b6f-cb84-e053-2995a90a361b 2024-12-05 Warnings Exact identifier application number: M013 Menstrual Complete Maximum Strength ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE L.N.K. International, Inc. 379ef03c-3b6a-40c3-b736-99f0537d26c8 2024-12-05 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN Marc Glassman, Inc. 43bf297f-2832-424f-a013-4bfa1d6c03e6 2024-12-04 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. 5a68ab98-720c-479a-a60a-4e594add6c09 2024-12-04 Warnings Exact identifier application number: M013 HEB Effervescent Pain Relief ASPIRIN H. E. BUTT GROCERY COMPANY 03876c71-60ec-3280-e063-6294a90a62dc 2024-12-03 Warnings Exact identifier application number: M013 Migrafein FORTE ACETAMINOPHEN, CAFFEINE OPMX LLC 028875c9-4129-ce2c-e063-6294a90a26cc 2024-12-03 Warnings Exact identifier application number: M013 Neo-Lubrina Fuerte ACETAMINOPHEN, CAFFEINE OPMX LLC 0288a327-fd4b-1991-e063-6294a90ace50 2024-12-03 Warnings Exact identifier application number: M013 CAFIZETAMOL FORTE ACETAMINOPHEN, CAFFEINE OPMX LLC 028771d3-a514-f7a5-e063-6394a90ac4f3 2024-12-03 Warnings Exact identifier application number: M013 Buscapina ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE OPMX LLC 048c4b03-1cf4-b724-e063-6294a90a1cad 2024-12-03 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN TopCo Associates LLC ecd6df7e-e7e2-446b-85ef-25971281fe31 2024-12-03 Warnings Exact identifier application number: M013 Market Basket Effervescent Pain Relief ASPIRIN DEMOULAS SUPER MARKETS, INC. 08133bf0-3c8f-e4d0-e063-6294a90af79a 2024-12-03 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN WinCo Foods, LLC 4359da13-e851-440b-91b9-6b544bff20d2 2024-12-03 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN WinCo Foods, LLC 5b3e8a78-5357-42ad-811e-b2578b25dc7b 2024-12-03 Warnings Exact identifier application number: M013 Low Strength Chewable Aspirin ASPIRIN Geri-Care Pharmaceutical Corp cc77b9d1-7874-4ce8-a763-3a0e1c2891de 2024-12-03 Warnings Exact identifier application number: M013 Good Sense Childrens Pain and Fever ACETAMINOPHEN L. Perrigo Company c6b79501-d08b-4430-9545-70da5f545975 2024-12-03 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Chain Drug Marketing Association 0e3be5f4-bc1b-4b44-a86a-ace89f6ee592 2024-12-02 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