Nighttime Sleep-Aid

Product NDC
53942-522
11-digit product format
539420522
Labeler code
53942
Product ID
53942-522_1e87d9fb-3c88-4c4e-8a3e-1c8b9458d6fa
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
DeMoulas Market Basket
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-19
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
53942-522-28Nighttime Sleep-Aid354 mL in 1 BOTTLELIQUID3544

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-522NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]4Current NDC, Legacy NDC, 1 package rows20231231_d3f35102-94ed-4da0-9c29-312e5468fa05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNd3f35102-94ed-4da0-9c29-312e5468fa054
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDd3f35102-94ed-4da0-9c29-312e5468fa054
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYd3f35102-94ed-4da0-9c29-312e5468fa054
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYd3f35102-94ed-4da0-9c29-312e5468fa054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-522-2853942052228354 mL in 1 BOTTLE (53942-522-28) 354 ml2013-09-190000-00-00NoNoCurrent