FDA.reportPublic FDA data

Nighttime Sleep-Aid

Product NDC
11822-8002
11-digit product format
118228002
Labeler code
11822
Product ID
11822-8002_954b0408-15c9-481d-b873-e7dbec490a97
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Rite Aid Corporation
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nighttime Sleep-Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-8002-1Nighttime Sleep-Aid177 mL in 1 BOTTLE, PLASTICSOLUTION1776
11822-8002-2Nighttime Sleep-Aid355 mL in 1 BOTTLE, PLASTICSOLUTION3556
11822-8002-9Nighttime Sleep-Aid355 mL in 1 BOTTLE, PLASTICSOLUTION3556
11822-8002-9Nighttime Sleep-Aid2 in 1 PACKAGESOLUTION26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-8002NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) SOLUTION [RITE AID CORPORATION]5Current NDC, 4 package rows20241109_f8d50b4e-735d-4d91-a18d-be3537e46e99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNf8d50b4e-735d-4d91-a18d-be3537e46e996
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDf8d50b4e-735d-4d91-a18d-be3537e46e996
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYf8d50b4e-735d-4d91-a18d-be3537e46e996
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYf8d50b4e-735d-4d91-a18d-be3537e46e996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11822-8002-111822800201177 mL in 1 BOTTLE, PLASTIC (11822-8002-1) 177 ml2023-05-19NoNoCurrent
11822-8002-211822800202355 mL in 1 BOTTLE, PLASTIC (11822-8002-2) 355 ml2023-05-19NoNoCurrent
11822-8002-9118228002092 BOTTLE, PLASTIC in 1 PACKAGE (11822-8002-9) / 355 mL in 1 BOTTLE, PLASTIC2023-05-19NoNoCurrent