Home NDC 54738-116 Diphenhydramine Hydrochloride
Product NDC 54738-116
11-digit product format 547380116
Labeler code 54738
Product ID 54738-116_2a328f44-efc3-7e72-e063-6394a90a1d39
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Richmond Pharmaceuticals Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2000-02-15
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 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020477 Internal RxNorm lookup 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 54738-116-13 Diphenhydramine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 5 54738-116-01 Diphenhydramine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 2 54738-116-03 Diphenhydramine Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54738-116 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 1 package rows 20241228_f184b2aa-91a4-44f9-b688-d4e318181984.zip 54738-116 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20171030_ab67121e-2477-47dd-a7ec-114453df3fd4.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 · 3,552 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54738-116-01 54738011601 100 CAPSULE in 1 BOTTLE (54738-116-01) 100 capsule 2015-05-01 0000-00-00 No No Current 54738-116-03 54738011603 1000 CAPSULE in 1 BOTTLE (54738-116-03) 1000 capsule 2015-05-01 0000-00-00 No No Current 54738-116-13 54738011613 100 CAPSULE in 1 BOTTLE (54738-116-13) 100 capsule 2000-02-15 0000-00-00 No No Current