FDA.reportPublic FDA data

Vicks ZzzQuil

Product NDC
84126-306
11-digit product format
841260306
Labeler code
84126
Product ID
84126-306_4ecd7f52-57c2-a89d-e063-6294a90ac7b1
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
KIT
Labeler
The Procter & Gamble Manufacturing Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-15
Marketing end
2027-03-06
NDC exclude flag
No
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
Vicks ZzzQuil
Brand name suffix
Nighttime Sleep-Aid

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1248354Internal RxNorm lookup
1248356Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1be2f00b-5bdd-82e7-e063-6394a90ab9a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-500-12Vicks ZzzQuilNighttime Sleep-Aid354 mL in 1 BOTTLE, PLASTICLIQUID354 mL50 mg in 30mL3
37000-500-24Vicks ZzzQuilNighttime Sleep-Aid2 in 1 PACKAGE, COMBINATIONLIQUID50 mg in 30mL3
84126-306-03Vicks ZzzQuilNighttime Sleep-Aid1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-306VICKS ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 3 package rows20240715_1be2f00b-5bdd-82e7-e063-6394a90ab9a5.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 9 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Diphenhydramine HClDIPHENHYDRAMINE HCLBI-MART2914504a-ed42-4168-9e5c-f49407ed5a302025-05-20WarningsExact 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
Diphenhydramine HCl Maximum StrengthDIPHENHYDRAMINE HCLBi-Martb89c80aa-27ae-4fce-b574-8ee64bbae2752025-05-01WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI217a211e-b8bf-4119-a094-0e5e733d0b182025-04-21WarningsExact identifier
application number: M010
Vicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AIDACETAMINOPHEN, DIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company32bedbbc-b939-1bea-e063-6394a90a69342025-04-14WarningsExact 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 SolutionPSN1be2f00b-5bdd-82e7-e063-6394a90ab9a53
1248356ZzzQuil NIGHTTIME SLEEP-AID 50 MG in 30 mL Oral SolutionPSN1be2f00b-5bdd-82e7-e063-6394a90ab9a53
1248356diphenhydramine hydrochloride 1.67 MG/ML Oral Solution [Zzzquil]SBD1be2f00b-5bdd-82e7-e063-6394a90ab9a53
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD1be2f00b-5bdd-82e7-e063-6394a90ab9a53
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY1be2f00b-5bdd-82e7-e063-6394a90ab9a53
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY1be2f00b-5bdd-82e7-e063-6394a90ab9a53
1248356Zzzquil 1.67 MG/ML Oral SolutionSY1be2f00b-5bdd-82e7-e063-6394a90ab9a53
1248356Zzzquil 50 MG per 30 ML Oral SolutionSY1be2f00b-5bdd-82e7-e063-6394a90ab9a53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-500-1237000050012354 mL in 1 BOTTLE, PLASTIC354 mlHistorical
37000-500-24370000500242 in 1 PACKAGE, COMBINATIONHistorical
84126-306-03841260306031 KIT in 1 CARTON (84126-306-03) * 2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (37000-500-24) / 354 mL in 1 BOTTLE, PLASTIC (37000-500-12) 1 kit2024-07-152027-03-06NoNoHistorical