Home NDC 69168-263 Sleep Aid
Product NDC 69168-263
11-digit product format 691680263
Labeler code 69168
Product ID 69168-263_b9e7a97b-a3e9-427c-8cc5-9c94941409a1
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl 25 mg
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-03-03
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 Sleep Aid
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 1049630 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-263 SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH] 7 Current NDC, Legacy NDC, 5 package rows 20250515_dbbc535f-515a-4d9b-b799-34e60f5230bb.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 69168-263-30 69168026330 30 TABLET in 1 BOTTLE (69168-263-30) 30 tablet 2015-03-03 0000-00-00 No No Current 69168-263-54 69168026354 1 BAG in 1 CARTON (69168-263-54) / 16458 TABLET in 1 BAG 1 bag 2025-05-08 No No Current 69168-263-93 69168026393 24 TABLET in 1 BOX (69168-263-93) 24 tablet 2015-03-03 0000-00-00 No No Current 69168-263-98 69168026398 200 TABLET in 1 BOTTLE (69168-263-98) 200 tablet 2021-07-23 0000-00-00 No No Current