Home NDC 17714-021 Diphenhydramine Hydrochloride
Product NDC 17714-021
11-digit product format 177140021
Labeler code 17714
Product ID 17714-021_60f41580-e0b1-faad-e053-2a91aa0a9076
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Advance Pharmaceutical Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1989-10-05
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 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 · 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 17714-021-01 Diphenhydramine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 3 17714-021-10 Diphenhydramine Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17714-021 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.] 3 Current NDC, Legacy NDC, 2 package rows 20171223_e1275cf5-94a7-4a15-be5c-81af95f8dd24.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 1 of 1 · 1 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 17714-021-01 17714002101 100 CAPSULE in 1 BOTTLE (17714-021-01) 100 capsule 1989-10-05 0000-00-00 No No Current 17714-021-10 17714002110 1000 CAPSULE in 1 BOTTLE (17714-021-10) 1000 capsule 1989-10-05 0000-00-00 No No Current