Diphenhydramine Hydrochloride

Product NDC
63187-771
Requested package NDC
63187-771-20
11-digit product format
631870771
Labeler code
63187
Product ID
63187-771_880a5683-eb5b-4576-8218-9da10cbd1789
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-01-02
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63187-77163187-771-20DDiscontinued by firm2026-10-12

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
63187-771-20EA - Each63187-7711c2ce5fb-41fc-4f53-aefb-cc0adcae386f12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-771DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]5Legacy NDC20240123_278e5b4b-9495-4269-87f2-8897a48ff6f0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-771-206318707712020 CAPSULE in 1 BOTTLE (63187-771-20) 20 capsule2017-08-010000-00-00NoNoCurrent