FDA.reportPublic FDA data

NDC 70000-0174-01 - LEADER Nighttime Sleep-Aid

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70000-0174
Requested NDC
70000-0174-01
Package NDCs from labels
70000-0174-1, 70000-0174-2, 70000-0174-01
Manufacturer
CARDINAL HEALTH
Effective date
2025-10-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LEADER Nighttime Sleep-Aid - CARDINAL HEALTHCARDINAL HEALTH2025-10-14HUMAN OTC DRUG LABEL
LEADER Nighttime Sleep-Aid - CARDINAL HEALTHCARDINAL HEALTH2025-10-14HUMAN OTC DRUG LABEL

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 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

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

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 7 of 80 · 1,597 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLDOLGENCORP, LLCf2eacb1b-8b29-41ec-828a-c1f902ac09342026-07-06WarningsExact identifier
unii: TC2D6JAD40
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECamber Pharmaceuticals, Inc.f808ee14-fccf-4abe-b53a-a40b0b3bba032026-07-04Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d0dceb-c9a9-778e-e063-6294a90a2ad72026-07-04WarningsExact identifier
unii: TC2D6JAD40
BenadrylDIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d10292-e673-9896-e063-6294a90a56742026-07-04WarningsExact identifier
unii: TC2D6JAD40
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.e50b3f60-b827-426c-8e78-8447c89130fe2026-06-29WarningsExact identifier
unii: TC2D6JAD40
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLChain Drug Marketing Association, Inc.e58417f4-3575-4433-ac2e-b7bf9fe8ba102026-06-29WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC31755678-825c-b84a-e063-6294a90a5a832026-06-27WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC319e84fd-4033-f5eb-e063-6394a90aa2f32026-06-27WarningsExact identifier
unii: TC2D6JAD40
CalmCo Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC552d0e50-a58c-8e47-e063-6394a90a8f7b2026-06-26WarningsExact identifier
application number: M010
unii: TC2D6JAD40
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
unii: PDC6A3C0OX
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5532fd37-cdd6-97ab-e063-6394a90a3c772026-06-26WarningsExact identifier
unii: TC2D6JAD40
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5533e705-b8d5-71cf-e063-6394a90a20102026-06-26WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.