FDA.reportPublic FDA data

Nightime Sleep Aid

Product NDC
21130-711
11-digit product format
211300711
Labeler code
21130
Product ID
21130-711_49976883-488e-6649-e063-6394a90ad715
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
BETTER LIVING BRANDS LLC.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-12
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

Additional Listing Data#

Finished product
Yes
Brand name base
Nightime Sleep Aid
Listing expiration
2027-12-31

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
21130-711-01Nightime Sleep Aid354 mL in 1 BOTTLELIQUID3543
21130-711-02Nightime Sleep Aid2 in 1 PACKAGELIQUID23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-711NIGHTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BETTER LIVING BRANDS LLC.]2Current NDC, 2 package rows20250412_202bb1ff-3273-4872-e063-6294a90abebb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN202bb1ff-3273-4872-e063-6294a90abebb3
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD202bb1ff-3273-4872-e063-6294a90abebb3
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY202bb1ff-3273-4872-e063-6294a90abebb3
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY202bb1ff-3273-4872-e063-6294a90abebb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-711-0121130071101354 mL in 1 BOTTLE (21130-711-01) 354 ml2026-04-11NoNoHistorical
21130-711-02211300711022 BOTTLE in 1 PACKAGE (21130-711-02) / 354 mL in 1 BOTTLE (21130-711-01) 2 bottle2025-04-12NoNoHistorical