Home NDC 49348-413 Sunmark z-sleep
Product NDC 49348-413
11-digit product format 493480413
Labeler code 49348
Product ID 49348-413_cf5bc852-2009-47e8-8576-33388053d305
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Strategic Sourcing Services LLC
Application part338
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-01-31
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 24 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49348-413-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49348-413-02 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49348-413-02 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49348-413-02 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49348-413-02 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49348-413-02 cdf11ea48f46…ba0047e9e063…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 49348-413-02 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 49348-413-02 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 49348-413-02 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49348-413-02 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49348-413-02 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49348-413-02 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 SUNMARK Z-SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MCKESSON] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M SUNMARK Z-SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MCKESSON] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SUNMARK Z-SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MCKESSON] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SUNMARK Z-SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MCKESSON] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L SUNMARK Z-SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MCKESSON] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SUNMARK Z-SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MCKESSON] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SUNMARK Z-SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MCKESSON] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SUNMARK Z-SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MCKESSON] 2