FDA.reportPublic FDA data

Diphenhydramine HCl

Product NDC
55154-0683
11-digit product format
551540683
Labeler code
55154
Product ID
55154-0683_eb39b6ab-a763-429b-a0ad-621f78a4a534
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-06-03
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-0683DDiscontinued by firm2026-10-05
excluded packagepackage55154-068355154-0683-0DDiscontinued 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 · 4 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 packagepackage55154-0683-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55154-0683-0f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-0683-0EA - Each55154-0683e795f72b-f26f-4686-8b8d-fc0d976340b812021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]3
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-0683DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH 107, LLC]10Legacy NDC20231121_30de8b4e-fe79-4de8-81b9-985c6e8be2c3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-0683-05515406830010 BLISTER PACK in 1 BAG (55154-0683-0) > 1 CAPSULE in 1 BLISTER PACK10 blister pack2011-06-030000-00-00NoNoCurrent