Home NDC 63187-866 Diphenhydramine HCL
Product NDC 63187-866
11-digit product format 631870866
Labeler code 63187
Product ID 63187-866_d27b1389-9287-4f39-91de-0d76a87f4e05
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 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 Diphenhydramine HCL
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 63187-866-10 Diphenhydramine HCL 10 in 1 BOTTLE, PLASTIC CAPSULE 10 5 63187-866-30 Diphenhydramine HCL 30 in 1 BOTTLE, PLASTIC CAPSULE 30 5 63187-866-60 Diphenhydramine HCL 60 in 1 BOTTLE, PLASTIC CAPSULE 60 5 63187-866-90 Diphenhydramine HCL 90 in 1 BOTTLE, PLASTIC CAPSULE 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-866 DIPHENHYDRAMINE HCL CAPSULE [PROFICIENT RX LP] 5 Current NDC, Legacy NDC, 4 package rows 20240201_6e91b9c3-57e8-488b-ac70-d863cdf9d6e8.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 Marketing end Sample Exclude flag Status 63187-866-10 63187086610 10 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-10) 10 capsule 2020-07-10 0000-00-00 No No Current 63187-866-30 63187086630 30 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-30) 30 capsule 2017-06-01 0000-00-00 No No Current 63187-866-60 63187086660 60 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-60) 60 capsule 2017-06-01 0000-00-00 No No Current 63187-866-90 63187086690 90 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-90) 90 capsule 2017-06-01 0000-00-00 No No Current