Home NDC 71309-110-50 Sleep-EZ Nighttime Sleep Aid
Product NDC 71309-110
Requested package NDC 71309-110-50
11-digit product format 713090110
Labeler code 71309
Product ID 71309-110_c3a6790e-f944-66f0-e053-2a95a90a9812
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl 25 mg
Dosage form TABLET, COATED
Route ORAL
Labeler Safrel Pharmaceuticals, LLC.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2017-06-01
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 71309-110-01 Sleep-EZ Nighttime Sleep Aid 1000 in 1 BOTTLE TABLET, COATED 1000 3 71309-110-02 Sleep-EZ Nighttime Sleep Aid 2 in 1 POUCH TABLET, COATED 2 3 71309-110-05 Sleep-EZ Nighttime Sleep Aid 500 in 1 BOTTLE TABLET, COATED 500 3 71309-110-10 Sleep-EZ Nighttime Sleep Aid 100 in 1 BOTTLE TABLET, COATED 100 3 71309-110-25 Sleep-EZ Nighttime Sleep Aid 25 in 1 BOX TABLET, COATED 25 3 71309-110-25 Sleep-EZ Nighttime Sleep Aid 2 in 1 POUCH TABLET, COATED 2 3 71309-110-30 Sleep-EZ Nighttime Sleep Aid 30 in 1 BOTTLE TABLET, COATED 30 3 71309-110-30 Sleep-EZ Nighttime Sleep Aid 1 in 1 CARTON TABLET, COATED 1 3 71309-110-50 Sleep-EZ Nighttime Sleep Aid 50 in 1 BOX TABLET, COATED 50 3 71309-110-50 Sleep-EZ Nighttime Sleep Aid 2 in 1 POUCH TABLET, COATED 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71309-110 SLEEP-EZ NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET, COATED [SAFREL PHARMACEUTICALS, LLC.] 3 Legacy NDC, 10 package rows 20210613_87537ba2-f4d7-8ea3-e053-2a95a90acc38.zip
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 71309-110-50 71309011050 50 POUCH in 1 BOX (71309-110-50) > 2 TABLET, COATED in 1 POUCH 50 pouch 2017-06-01 0000-00-00 No No Current