Home NDC 59726-760 Sleep Aid
Product NDC 59726-760
11-digit product format 597260760
Labeler code 59726
Product ID 59726-760_ad9450db-aaad-4f7a-9c32-f3e1f33c0923
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCL
Dosage form CAPSULE
Route ORAL
Labeler P & L Development, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-29
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 Sleep Aid
Brand name suffix Maximum Strength
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 59726-760-29 Sleep AidMaximum Strength 2 in 1 BOX CAPSULE 2 4 59726-760-29 Sleep AidMaximum Strength 96 in 1 BOTTLE, PLASTIC CAPSULE 96 4 59726-760-64 Sleep AidMaximum Strength 1 in 1 BOX CAPSULE 1 4 59726-760-64 Sleep AidMaximum Strength 64 in 1 BOTTLE, PLASTIC CAPSULE 64 4 59726-760-92 Sleep AidMaximum Strength 96 in 1 BOTTLE, PLASTIC CAPSULE 96 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59726-760 SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE [P & L DEVELOPMENT, LLC] 4 Current NDC, Legacy NDC, 5 package rows 20231024_169006cb-7dc2-4113-a289-0b1f14e784b7.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 · 3,550 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 59726-760-29 59726076029 2 BOTTLE, PLASTIC in 1 BOX (59726-760-29) / 96 CAPSULE in 1 BOTTLE, PLASTIC 2019-11-29 No No Current 59726-760-64 59726076064 1 BOTTLE, PLASTIC in 1 BOX (59726-760-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC 2019-11-29 0000-00-00 No No Current 59726-760-92 59726076092 96 CAPSULE in 1 BOTTLE, PLASTIC (59726-760-92) 96 capsule 2019-11-29 0000-00-00 No No Current