FDA.reportPublic FDA data

NIGHT TIME SLEEP-AID

Product NDC
53943-522
11-digit product format
539430522
Labeler code
53943
Product ID
53943-522_6bad3d04-e840-405d-8fca-3cfa4e1b3477
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HCL
Dosage form
LIQUID
Route
ORAL
Labeler
Discount Drug Mart
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-12-10
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53943-522-28e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53943-522-25e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53943-522-289bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53943-522-259bebd1f3094a…5416666fcb17…

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
NIGHT TIME 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
ac1860cb-da95-45bf-9261-19f39c56ddfeAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53943-522-252020-12-31ac1860cb-da95-45bf-9261-19f39c56ddfe
53943-522-282020-12-31ac1860cb-da95-45bf-9261-19f39c56ddfe
53943-522-252020-01-31ac1860cb-da95-45bf-9261-19f39c56ddfe
53943-522-282020-01-31ac1860cb-da95-45bf-9261-19f39c56ddfe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-522-25NIGHT TIME SLEEP-AID117 mL in 1 BOTTLELIQUID1176
53943-522-28NIGHT TIME SLEEP-AID354 mL in 1 BOTTLELIQUID3546

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2NIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-522NIGHT TIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [DISCOUNT DRUG MART]5Current NDC, Legacy NDC, 2 package rows20241222_ac1860cb-da95-45bf-9261-19f39c56ddfe.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 8 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health sleep aidDIPHENHYDRAMINE HCLDolgencorp, LLC4c266acb-49ae-4d04-8602-0df35b22874a2025-07-10WarningsExact identifier
application number: M010
NIGHT TIME SLEEP-AIDDIPHENHYDRAMINE HCLAdvanced Rx LLC07c69e63-deb1-4607-9f7f-1cf0cd05cc822025-07-02WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MART896ae7b8-cb8d-1aaa-e053-2a95a90a4e1a2025-06-30WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)027d7eff-6c83-40f1-9716-231637cdbeba2025-06-12WarningsExact identifier
application number: M010
Nighttime Sleep Aid maximum strengthDIPHENHYDRAMINE HCLCardinal Health (Leader) 70000546e4fda-6eb2-4358-840e-e2473bf7f3522025-06-03WarningsExact identifier
application number: M010
Simply SleepDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC37c606b0-04d5-49f0-886a-3ee2c9b0e9cc2025-06-02WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLWinCo Foods, LLCe9bc5a16-b1fc-4585-8f3b-30ccf43004922025-05-30WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCare One (Retail Business Services, LLC.)51e633a8-5bfc-4ff9-816f-3bc22b8a5c4c2025-05-23WarningsExact identifier
application number: M010
Nighttime Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLCare One (Retail Business Services, LLC.)536cd7d6-a470-4614-89c8-6c3ada582a902025-05-23WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCardinal Health (Leader) 70000133d6f38-9de7-4104-8175-3933b263afe02025-05-16WarningsExact identifier
application number: M010
Nighttime Sleep-aidDIPHENHYDRAMINE HCLNORTHEAST PHARMAd2062094-d1b5-38ab-e053-2995a90a56702025-05-15WarningsExact identifier
application number: M010
Nighttime Sleep-aidDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corp0fce381f-28ef-4591-a569-c5d599a3b95f2025-05-14WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association54bdb6bc-622c-412a-8365-a1b1c968e13e2025-05-01WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI217a211e-b8bf-4119-a094-0e5e733d0b182025-04-21WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)25f32a1c-0687-45e9-8142-96cf635990902025-04-03WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLFSA Store Inc. (Caring Mills)9d32a3a1-9528-4de4-9fd1-1d01a1ad93e92025-03-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLWR Group, Inc.d28d0f6d-8029-4e31-b417-4f8f864d840e2025-03-28WarningsExact identifier
application number: M010
Sleep Aid NightTimeDIPHENHYDRAMINE HCLP & L Development, LLC4144b1a6-aeae-4560-a997-b07206d803502025-03-24WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCa512413c-639b-4846-b016-332a78b50ab72025-03-21WarningsExact identifier
application number: M010
Diphenhydramine HClDIPHENHYDRAMINE HCLPD-Rx Pharmaceuticals, Inc.1ee41c86-6767-43ca-a5bb-fc685fa662cd2025-03-20WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNac1860cb-da95-45bf-9261-19f39c56ddfe6
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDac1860cb-da95-45bf-9261-19f39c56ddfe6
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYac1860cb-da95-45bf-9261-19f39c56ddfe6
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYac1860cb-da95-45bf-9261-19f39c56ddfe6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-522-2553943052225117 mL in 1 BOTTLE (53943-522-25) 117 ml2013-12-100000-00-00NoNoCurrent
53943-522-2853943052228354 mL in 1 BOTTLE (53943-522-28) 354 ml2013-12-100000-00-00NoNoCurrent