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 1 of 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay AwakeCAFFEINEUnited Natural Foods, Inc. dba UNFI15e4d040-ed21-46e7-98c6-56267f388f572026-08-21WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEGeiss, Destin & Dunn Inc.a4c796a8-6685-4214-bf08-10ee2735ea122026-07-09WarningsExact identifier
application number: M011
Stay Awake Maximum StrengthCAFFEINEUnited Natural Foods, Inc. dba UNFI1357eade-f1d3-4df2-8a8a-4c318aab11412026-06-15WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEWal-Mart Stores Inc5f5b65a2-4db7-4c8e-a954-95611a0872172026-06-08WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEShield Pharmaceuticals Corp82c582ce-1360-4c4f-b9a7-a5a43cf5fd2c2026-05-18WarningsExact identifier
application number: M011
AlertCAFFEINEDOLGENCORP, LLC9e47eed8-4d0f-4a26-b761-578fb593f0252026-05-06WarningsExact identifier
application number: M011
stay awakeCAFFEINERite Aid Corporatione33e353c-3af4-4e91-bd76-fa09860fee432026-05-06WarningsExact identifier
application number: M011
VIVARINCAFFEINEVespyr Brands LLC4537a56b-e875-4961-9fff-3f778746f1262026-05-01WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEStrategic Sourcing Services LLC49f408a8-b182-4172-84aa-390bff31d5d52026-05-01WarningsExact identifier
application number: M011
Stay AwakeCAFFEINESalado Sales, Inc.2bb2176f-baae-4314-af6a-9150da7017a52026-04-29WarningsExact identifier
application number: M011
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Weitapai E-commerce Co., Ltd.4f699c20-63ff-35c5-e063-6294a90a018b2026-04-14WarningsExact identifier
application number: M011
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSGuangzhou Zhenxiang E-commerce Co., Ltd.4f11f1ce-389d-2523-e063-6294a90aba502026-04-09WarningsExact identifier
application number: M011
ALLBIZR IRON SHOGUN SMELLING SALTSAMMONIAHong Kong Xile International Trading Limited4eba5d6e-dc7b-5d69-e063-6294a90a7b4a2026-04-05WarningsExact identifier
application number: M011
Stay Awake Maximum StrengthCAFFEINEBetter Living Brands, LLC976780f9-228c-44cb-b1f4-8027280fc7cb2026-03-11WarningsExact identifier
application number: M011
CaffeineCAFFEINECVS Pharmacy, Inc.6d9b3926-7198-5e00-e053-2a91aa0a95802026-02-24WarningsExact identifier
application number: M011
CaffeineCAFFEINELEADER/ Cardinal Health 110, Inc.7c4d61f7-9c6a-61ac-e053-2991aa0a95332026-01-28WarningsExact identifier
application number: M011
Awake Maximum StrengthCAFFEINEBetter Living Brands, LLCce4da457-805f-4d2a-8667-6516eea852212026-01-21WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEARMY AND AIR FORCE EXCHANGE SERVICE44d60bfb-4320-4f5b-8a22-9a984805ddaf2026-01-06WarningsExact identifier
application number: M011
SYBORG SALTS Smelling SaltAMMONIUM CARBONATE AND SODIUM CARBONATEDirect Outlet Supplier LLCb9a9d589-00ef-4464-9a50-985d0d71664f2026-01-06WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEVALU MERCHANDISERS COMPANYb2ae7941-5711-4046-b715-bc77cc04becb2025-12-11WarningsExact 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