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 10 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Inc.6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f2024-12-02WarningsExact identifier
application number: M010
Diphenhydramine HClDIPHENHYDRAMINE HCLCVS Pharmacy, Inc.6dd802ec-fc26-3913-e053-2a91aa0ad05d2024-12-02WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC236ff457-0ec1-9c49-e063-6394a90a707a2024-11-26WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.50d74111-6d1b-4681-a264-f7e5503202592024-11-25WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.efb05387-72c0-4643-8541-b7990c202ce62024-11-25WarningsExact identifier
application number: M010
Nighttime Sleep Aid, 24-7 Life BY 7-ELEVEN, 6ozDIPHENHYDRAMINE HCL SOLUTIONLil' Drug Store Products, Inc.2781fc28-8a7d-d0fa-e063-6394a90ac7932024-11-22WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.7830ce18-908a-4f86-a238-8c31cfe47ce62024-11-21WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.f8de6605-4a0a-492d-beb5-f414ce8bfb0e2024-11-20WarningsExact identifier
application number: M010
Nighttime SLEEP AIDDIPHENHYDRAMINE HCL 50MGPuraCap Pharmaceutical LLC272a7138-2a97-8e62-e063-6394a90a1af12024-11-18WarningsExact identifier
application number: M010
ZzzQuilDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.0b2777be-85d4-443d-b65f-6750e0ba97ba2024-11-18WarningsExact identifier
application number: M010
RiteAid Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENRITE AID CORPORATION54fc0893-9702-4849-a702-3e84dc9ead032024-10-30WarningsExact identifier
application number: M010
Rite Aid Nighttime Sleep Aid Non Habit FormingDIPHENHYDRAMINE HYDROCHLORIDERITE AID CORPORATION59ba6824-fa6c-4b3f-9f1f-ea194766c8a12024-10-30WarningsExact identifier
application number: M010
GOOD REMEDIES Nighttime Sleep Aid CapletsDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fba735-cedf-9d15-e063-6394a90af8732024-10-29WarningsExact identifier
application number: M010
Premier Value Nighttime Sleep-Aid Liquid Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Consortium6d24b6e1-7959-47c6-a09b-c7e00a4374952024-10-28WarningsExact identifier
application number: M010
NytolDIPHENHYDRAMINE HCLMedtech Products Inc.c81d018a-0170-4396-81e9-2e13a53f868a2024-10-25WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.2ab3852d-53a4-411b-a9ad-3ef88ab3ee872024-10-23WarningsExact identifier
application number: M010
nitetime sleep aidDIPHENHYDRAMINE HCLMeijer Distribution Inc43184abd-2525-402a-a388-85af2e5c13ad2024-10-17WarningsExact identifier
application number: M010
Good Sense Sleep TimeDIPHENHYDRAMINE HCLL. Perrigo Company164200a9-b1f8-44c9-8598-a7dff5020e9d2024-10-16WarningsExact identifier
application number: M010
Equaline Night Time Sleep AidDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI6d34ee3e-3d61-481e-98d6-acfa066e42472024-10-16WarningsExact identifier
application number: M010
basic care nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLC027de5ea-5c07-4960-8a98-8cf2c0e54a922024-10-16WarningsExact 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