Home NDC 77333-231 Antihistamine
Product NDC 77333-231
11-digit product format 773330231
Labeler code 77333
Product ID 77333-231_50fab60d-a209-cf04-e063-6294a90ab007
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form CAPSULE
Route ORAL
Labeler Gendose Pharmaceuticals, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-15
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Antihistamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020477 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 77333-231-10 Antihistamine 100 in 1 BOX CAPSULE 100 1 77333-231-25 Antihistamine 1 in 1 BLISTER PACK CAPSULE 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 77333-231-10 77333023110 100 BLISTER PACK in 1 BOX (77333-231-10) / 1 CAPSULE in 1 BLISTER PACK (77333-231-25) 100 blister pack 2026-05-15 No No Current 77333-231-25 77333023125 1 in 1 BLISTER PACK Historical