FDA.reportPublic FDA data

LEADER Nighttime Sleep-Aid

Product NDC
70000-0174
11-digit product format
700000174
Labeler code
70000
Product ID
70000-0174_411d160c-a158-8f91-e063-6394a90a77f0
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
CARDINAL HEALTH
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-13
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

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
LEADER 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
6fe34d05-84a4-4254-aea6-77b52122ea18Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0174-1LEADER Nighttime Sleep-Aid354 mL in 1 BOTTLE, PLASTICLIQUID3548
70000-0174-2LEADER Nighttime Sleep-Aid177 mL in 1 BOTTLE, PLASTICLIQUID1777

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0174-1ML - Milliliter70000-01742328120d-fda2-434f-a608-f72d9320b56e12020-06-05
70000-0174-2ML - Milliliter70000-017484192197-797f-46d0-86cc-b50ea2a6977412020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0174LEADER NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CARDINAL HEALTH]7Current NDC, Legacy NDC, 1 package rows20241122_68c79c47-11bf-4b51-ace0-723cac7a4620.zip
70000-0174LEADER NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CARDINAL HEALTH]6Current NDC, Legacy NDC, 1 package rows20241122_6fe34d05-84a4-4254-aea6-77b52122ea18.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 4 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leader1d73e966-aa4a-40a0-b42a-fda8e500756e2026-03-13WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreensea1b5ec1-3c8e-437d-8e37-f38ab66d9f782026-03-13WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8dc17b5d-1cf7-44d2-9e78-d2c6952c7d202026-03-11WarningsExact identifier
application number: M010
sleep aidDIPHENHYDRAMINE HCLRite Aid Corporationbdfd7d87-2b54-4c29-ba69-aad0fab682e72026-03-11WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWal-Mart Stores Inc5ef35ab9-b6e8-4c88-a623-35ac9d6bd3592026-03-05WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLWALMART INC. (see also Equate)84c37f4d-60f6-490e-ba8b-47d1257fa6f82026-02-13WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLP & L Development, LLC59c063ad-6ea3-4f1d-a20e-5e5e062a90982026-02-10WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLWinCo Foods, LLCf446e56f-c664-4092-8712-aa3f204172f82026-02-02WarningsExact identifier
application number: M010
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLCd805fab3-9dca-497f-bdc6-c8a7b17361092026-01-27WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0e45d0e8-3741-7cee-e063-6394a90a2de52026-01-27WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd335b09c6-ee5d-ebdf-e063-6294a90abd122026-01-27WarningsExact identifier
application number: M010
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd32033991-a4f0-f767-e063-6394a90a0b062026-01-27WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Inc90506598-046f-48d3-b8f5-d6ead03338122026-01-27WarningsExact identifier
application number: M010
DORMMY-LONDIPHENHYDRAMINE HYDROCHLORIDEHaendel Farma, S.A. de C.V.562db961-83cb-4b74-9f34-fecee2c1be172026-01-27WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLBetter Living Brands, LLCdec955d3-817d-454f-b146-9a631e908dbc2026-01-27WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEProdose, Inc.c4bc3efd-8ca8-22fe-e053-2a95a90aed452026-01-26WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANYf000d0b5-8ee8-4db0-99fe-aae5ed20c98e2026-01-19WarningsExact identifier
application number: M010
Unisom SleepMinis Nighttime Sleep-AidDIPHENHYDRAMINE HCLChattem, Inc.a9a44c2f-65eb-4a5a-9e72-43652dce57f72026-01-14WarningsExact identifier
application number: M010
Unisom SleepMelts Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.9105f4f1-7f94-408d-a025-83afb68dc9f02026-01-14WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC462ca6cd-8eec-09df-e063-6294a90ac8802026-01-13WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN68c79c47-11bf-4b51-ace0-723cac7a46208
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD68c79c47-11bf-4b51-ace0-723cac7a46208
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY68c79c47-11bf-4b51-ace0-723cac7a46208
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY68c79c47-11bf-4b51-ace0-723cac7a46208
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN6fe34d05-84a4-4254-aea6-77b52122ea187
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD6fe34d05-84a4-4254-aea6-77b52122ea187
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY6fe34d05-84a4-4254-aea6-77b52122ea187
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY6fe34d05-84a4-4254-aea6-77b52122ea187

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0174-170000017401354 mL in 1 BOTTLE, PLASTIC (70000-0174-1) 354 ml2017-01-170000-00-00NoNoCurrent
70000-0174-270000017402177 mL in 1 BOTTLE, PLASTIC (70000-0174-2) 177 ml2017-03-130000-00-00NoNoCurrent