FDA.reportPublic FDA data

Siladryl Allergy Medicine

Product NDC
54838-135
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54838-135DDiscontinued by firm2026-10-05
excluded packagepackage54838-13554838-135-40DDiscontinued by firm2026-10-05
excluded packagepackage54838-13554838-135-70DDiscontinued by firm2026-10-05
excluded packagepackage54838-13554838-135-80DDiscontinued by firm2026-10-05

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54838-135-70d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54838-135-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54838-135-80d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54838-135-70f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54838-135-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54838-135-80f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54838-135-702ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54838-135-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54838-135-802ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54838-135-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54838-135-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54838-135-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54838-135-70cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54838-135-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54838-135-80cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54838-135-70cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54838-135-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54838-135-80cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54838-135-70302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54838-135-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54838-135-80302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54838-135-70ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54838-135-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54838-135-80ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54838-135-700efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54838-135-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54838-135-800efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54838-135-40ML - Milliliter54838-13587d16fcc-e01c-4b61-ae11-a13ea6bb905612012-07-24
54838-135-70ML - Milliliter54838-135f13f7b19-421d-47eb-a27f-5cdbb6c15d2612012-07-24
54838-135-80ML - Milliliter54838-1354a60ef46-6956-40fc-bc99-ce529980ed8c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
diphenhydramineACTIVE MOIETY8GTS82S83MSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0LSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOASILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
saccharin sodium dihydrateINACTIVE INGREDIENTSB8ZUX40TYSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
sorbitolINACTIVE INGREDIENT506T60A25RSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
waterINACTIVE INGREDIENT059QF0KO0RSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]14
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
diphenhydramineACTIVE MOIETY8GTS82S83MSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0LSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOASILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
sorbitolINACTIVE INGREDIENT506T60A25RSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RSILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN717c622c-570e-47d4-be73-041a88e8ebf81
1094393Siladryl Allergy 12.5 MG in 5 mL Oral SolutionPSN717c622c-570e-47d4-be73-041a88e8ebf81
1094393diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Siladryl]SBD717c622c-570e-47d4-be73-041a88e8ebf81
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD717c622c-570e-47d4-be73-041a88e8ebf81
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY717c622c-570e-47d4-be73-041a88e8ebf81
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY717c622c-570e-47d4-be73-041a88e8ebf81
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY717c622c-570e-47d4-be73-041a88e8ebf81
1094393Siladryl 2.5 MG/ML Oral SolutionSY717c622c-570e-47d4-be73-041a88e8ebf81
1094393Siladryl DAS 2.5 MG/ML Oral SolutionSY717c622c-570e-47d4-be73-041a88e8ebf81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54838-135-4054838013540118 mL in 1 BOTTLE (54838-135-40) 118 ml1997-01-010000-00-00NoNoCurrent
54838-135-7054838013570237 mL in 1 BOTTLE (54838-135-70) 237 ml1997-01-010000-00-00NoNoCurrent
54838-135-8054838013580473 mL in 1 BOTTLE (54838-135-80) 473 ml1997-01-010000-00-00NoNoCurrent