Allergy Relief

Product NDC
55681-322
Requested package NDC
55681-322-03
11-digit product format
556810322
Labeler code
55681
Product ID
55681-322_e4a47143-2d18-d1ba-e053-2a95a90a17cc
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TWIN MED LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-07-15
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55681-32255681-322-03DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-322ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TWIN MED LLC]3Legacy NDC20240114_e4a47131-8017-3d92-e053-2a95a90a619e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55681-322-0355681032203300 TABLET in 1 BOTTLE (55681-322-03) 300 tablet2022-07-150000-00-00NoNoCurrent