FDA.reportPublic FDA data

Diphenhist

Product NDC
0536-1010
11-digit product format
005361010
Labeler code
0536
Product ID
0536-1010_a6155b5c-4dff-1f43-e053-2a95a90a740b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Rugby Laboratories
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-03-17
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct0536-1010DDiscontinued by firm2026-10-05
excluded packagepackage0536-10100536-1010-01DDiscontinued 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 packagepackage0536-1010-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-1010-01f5e01cc5f278…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
0536-1010-01EA - Each0536-1010c08f0fdf-221b-4f65-af50-99e9b02572e512014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHIST (DIPHENHYDRAMINE HCL) CAPSULE [RUGBY LABORATORIES]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHIST (DIPHENHYDRAMINE HCL) CAPSULE [RUGBY LABORATORIES]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHIST (DIPHENHYDRAMINE HCL) CAPSULE [RUGBY LABORATORIES]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHIST (DIPHENHYDRAMINE HCL) CAPSULE [RUGBY LABORATORIES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHIST (DIPHENHYDRAMINE HCL) CAPSULE [RUGBY LABORATORIES]1
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHIST (DIPHENHYDRAMINE HCL) CAPSULE [RUGBY LABORATORIES]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIPHENHIST (DIPHENHYDRAMINE HCL) CAPSULE [RUGBY LABORATORIES]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENHIST (DIPHENHYDRAMINE HCL) CAPSULE [RUGBY LABORATORIES]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1010-0100536101001100 CAPSULE in 1 BOTTLE (0536-1010-01) 100 capsule2014-03-170000-00-00NoNoCurrent