Home NDC 54838-154-80 Silphen
Product NDC 54838-154
Requested package NDC 54838-154-80
11-digit product format 548380154
Labeler code 54838
Product ID 54838-154_55ba2a3d-ba0d-4f50-88aa-ee45b5ea5592
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Lannett Company, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1993-12-03
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 13 mg/5mL
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 · 12 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…
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 SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 Diphenhydramine ACTIVE MOIETY 8GTS82S83M SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 Alcohol INACTIVE INGREDIENT 3K9958V90M SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 ammonium chloride INACTIVE INGREDIENT 01Q9PC255D SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 D&C red no. 33 INACTIVE INGREDIENT 9DBA0SBB0L SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 menthol INACTIVE INGREDIENT L7T10EIP3A SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 sucrose INACTIVE INGREDIENT C151H8M554 SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17 water INACTIVE INGREDIENT 059QF0KO0R SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC] 17
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-154-80 54838015480 473 mL in 1 BOTTLE, PLASTIC (54838-154-80) 473 ml 1993-12-03 0000-00-00 No No Current