FDA.reportPublic FDA data

Sleep Aid

Product NDC
69168-431
11-digit product format
691680431
Labeler code
69168
Product ID
69168-431_8f729339-eda6-456a-bdc5-445eff09ff66
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Allegiant Health
Application
M011
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-21
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9746911a-36bc-45eb-adfd-e96439d7a865Available on FDA.report

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
69168-431-03Sleep Aid250 in 1 BOTTLECAPSULE, LIQUID FILLED2504
69168-431-86Sleep Aid12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
69168-431-86Sleep Aid1 in 1 CARTONCAPSULE, LIQUID FILLED14
69168-431-96Sleep Aid96 in 1 BOTTLECAPSULE, LIQUID FILLED964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-431SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]4Current NDC, Legacy NDC, 4 package rows20250515_9746911a-36bc-45eb-adfd-e96439d7a865.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 3 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay AwakeCAFFEINEAAA Pharmaceutical, Inc.14967dc9-d223-d954-e063-6394a90aa6762024-06-13WarningsExact identifier
application number: M011
JET ALERT Regular StrengthCAFFEINEBell Pharmaceuticals, Inccd7366f9-6ee9-4f1d-bfd2-3ce067f59b2d2023-12-15WarningsExact identifier
application number: M011
Sleep AidDIPHENHYDRAMINE HCLAllegiant Health9746911a-36bc-45eb-adfd-e96439d7a8652021-08-30WarningsExact identifier
application number: M011
ndc (product): 69168-431
Topcare Stay Awake Maximum StrengthCAFFEINETopCo Associates, LLC2223cf52-c172-462d-aacc-b069849b74412021-04-28WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEAllegiant Health959b50a1-3037-4f94-8bc5-6515018150922019-01-08WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEMarc Glassman, Inc.fda5b0a8-2c85-4a8b-97ab-777682c816e22016-12-21WarningsExact identifier
application number: M011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN9746911a-36bc-45eb-adfd-e96439d7a8654
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD9746911a-36bc-45eb-adfd-e96439d7a8654

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-431-0369168043103250 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-03) 2023-04-30NoNoCurrent
69168-431-86691680431861 BLISTER PACK in 1 CARTON (69168-431-86) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2021-09-210000-00-00NoNoCurrent
69168-431-966916804319696 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-96) 2021-09-210000-00-00NoNoCurrent