Home NDC 68788-8855 Diphenhydramine Hydrochloride
Product NDC 68788-8855
11-digit product format 687888855
Labeler code 68788
Product ID 68788-8855_9382c976-3067-4923-a38f-101d1c481e97
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-11
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 2026-12-31
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 Diphenhydramine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 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 1049909 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 68788-8855-0 Diphenhydramine Hydrochloride 10 in 1 BOTTLE CAPSULE 10 1 68788-8855-1 Diphenhydramine Hydrochloride 15 in 1 BOTTLE CAPSULE 15 1 68788-8855-3 Diphenhydramine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8855 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.] 1 Current NDC, 3 package rows 20250413_9382c976-3067-4923-a38f-101d1c481e97.zip
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 73 of 178 · 3,551 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 68788-8855-0 68788885500 10 CAPSULE in 1 BOTTLE (68788-8855-0) 10 capsule 2025-04-11 No No Current 68788-8855-1 68788885501 15 CAPSULE in 1 BOTTLE (68788-8855-1) 15 capsule 2025-04-11 No No Current 68788-8855-3 68788885503 30 CAPSULE in 1 BOTTLE (68788-8855-3) 30 capsule 2025-04-11 No No Current