Home NDC 54838-135-70 Siladryl Allergy Medicine
Product NDC 54838-135
Requested package NDC 54838-135-70
11-digit product format 548380135
Labeler code 54838
Product ID 54838-135_cb6d2fa4-3d1a-4c5d-96f7-bf562c7c833b
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Lannett Company, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1997-01-01
Marketing end 2024-11-30
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 13 mg/5mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 · 9 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded diphenhydramine hydrochloride ACTIVE INGREDIENT TC2D6JAD40 SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 diphenhydramine ACTIVE MOIETY 8GTS82S83M SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 D&C red no. 33 INACTIVE INGREDIENT 9DBA0SBB0L SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 saccharin sodium dihydrate INACTIVE INGREDIENT SB8ZUX40TY SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 sorbitol INACTIVE INGREDIENT 506T60A25R SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 water INACTIVE INGREDIENT 059QF0KO0R SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 diphenhydramine hydrochloride ACTIVE INGREDIENT TC2D6JAD40 SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 diphenhydramine ACTIVE MOIETY 8GTS82S83M SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 D&C red no. 33 INACTIVE INGREDIENT 9DBA0SBB0L SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 sorbitol INACTIVE INGREDIENT 506T60A25R SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1 water INACTIVE INGREDIENT 059QF0KO0R SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP] 1
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 54838-135-70 54838013570 237 mL in 1 BOTTLE (54838-135-70) 237 ml 1997-01-01 2024-11-30 No No Current