Home NDC 15127-258 Sleep Tabs
Product NDC 15127-258
11-digit product format 151270258
Labeler code 15127
Product ID 15127-258_6f9739fa-4e82-47c3-a290-11699bf23677
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET
Route ORAL
Labeler L&R Distributors, Inc.
Application part338
Marketing category OTC MONOGRAPH FINAL
Marketing start 1990-04-10
Marketing end 2021-08-03
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 15127-258-16 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 15127-258-16 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 15127-258-16 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 15127-258-16 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 15127-258-16 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 15127-258-16 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 15127-258-16 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 15127-258-16 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 15127-258-16 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 15127-258-16 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 15127-258-16 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 15127-258-16 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 SLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 7 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M SLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 7 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J SLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 15127-258-16 15127025816 2 BLISTER PACK in 1 CARTON (15127-258-16) > 8 TABLET in 1 BLISTER PACK 2 blister pack 1990-04-10 2021-08-03 No No Current