Home NDC 71205-615 Diphenhydramine HCL
Product NDC 71205-615
11-digit product format 712050615
Labeler code 71205
Product ID 71205-615_49763843-7dc9-4416-a2c8-c49f84337322
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCL
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-01-27
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 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 Diphenhydramine HCL
Listing expiration 2027-12-31 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 71205-615-20 Diphenhydramine HCL 20 in 1 BOTTLE, PLASTIC CAPSULE 20 3 71205-615-30 Diphenhydramine HCL 30 in 1 BOTTLE, PLASTIC CAPSULE 30 3 71205-615-60 Diphenhydramine HCL 60 in 1 BOTTLE, PLASTIC CAPSULE 60 3 71205-615-90 Diphenhydramine HCL 90 in 1 BOTTLE, PLASTIC CAPSULE 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-615 DIPHENHYDRAMINE HCL CAPSULE [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 4 package rows 20240112_5943d975-77e4-4cbd-b2d9-d699052fe82a.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 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 Marketing end Sample Exclude flag Status 71205-615-20 71205061520 20 CAPSULE in 1 BOTTLE, PLASTIC (71205-615-20) 20 capsule 2024-01-02 No No Current 71205-615-30 71205061530 30 CAPSULE in 1 BOTTLE, PLASTIC (71205-615-30) 30 capsule 2021-10-20 0000-00-00 No No Current 71205-615-60 71205061560 60 CAPSULE in 1 BOTTLE, PLASTIC (71205-615-60) 60 capsule 2021-10-20 0000-00-00 No No Current 71205-615-90 71205061590 90 CAPSULE in 1 BOTTLE, PLASTIC (71205-615-90) 90 capsule 2021-10-20 0000-00-00 No No Current