Home NDC 55910-981 Sleep Aid
Product NDC 55910-981
11-digit product format 559100981
Labeler code 55910
Product ID 55910-981_dcba89a4-11b0-431e-88b3-7aba217b2637
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCL
Dosage form LIQUID
Route ORAL
Labeler Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-04
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 50 mg/30mL
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 NightTime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL
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 1248354 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 55910-981-02 Sleep AidNightTime 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 5 55910-981-04 Sleep AidNightTime 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 5 55910-981-04 Sleep AidNightTime 2 in 1 PACKAGE LIQUID 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-981 SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)] 4 Current NDC, Legacy NDC, 3 package rows 20240731_4fff664b-4ff0-4007-95ab-cb273807b9b4.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 98 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 55910-981-02 55910098102 355 mL in 1 BOTTLE, PLASTIC (55910-981-02) 355 ml 2022-02-04 0000-00-00 No No Current 55910-981-04 55910098104 2 BOTTLE, PLASTIC in 1 PACKAGE (55910-981-04) / 355 mL in 1 BOTTLE, PLASTIC 2022-02-04 0000-00-00 No No Current