FDA.reportPublic FDA data

Nighttime Sleep-Aid

Product NDC
53041-633
11-digit product format
530410633
Labeler code
53041
Product ID
53041-633_329d343f-2056-4870-930c-348917bfb2bc
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Guardian Drug Company
Application
part338
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-11
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1248354Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
329d343f-2056-4870-930c-348917bfb2bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-633-58Nighttime Sleep-Aid177 mL in 1 BOTTLELIQUID1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-633NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1Current NDC, 1 package rows20240113_329d343f-2056-4870-930c-348917bfb2bc.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep-AidDIPHENHYDRAMINE HCLGuardian Drug Company329d343f-2056-4870-930c-348917bfb2bc2024-01-11WarningsExact identifier
ndc (product): 53041-633

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN329d343f-2056-4870-930c-348917bfb2bc1
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD329d343f-2056-4870-930c-348917bfb2bc1
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY329d343f-2056-4870-930c-348917bfb2bc1
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY329d343f-2056-4870-930c-348917bfb2bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53041-633-5853041063358177 mL in 1 BOTTLE (53041-633-58) 177 ml2024-01-11NoNoCurrent