FDA.reportPublic FDA data

VICKS ZzzQuil FREE and CLEAR

Product NDC
84126-370
Requested package NDC
84126-370-24
11-digit product format
841260370
Labeler code
84126
Product ID
84126-370_5ce13eaf-b654-1e98-e063-6294a90ab284
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-03
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
2027-12-31
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
VICKS ZzzQuil FREE and CLEAR
Brand name suffix
NIGHTTIME SLEEP-AID
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-370-12VICKS ZzzQuil FREE and CLEARNIGHTTIME SLEEP-AID354 mL in 1 BOTTLE, PLASTICLIQUID3541
84126-370-24VICKS ZzzQuil FREE and CLEARNIGHTTIME SLEEP-AID354 mL in 1 BOTTLE, PLASTICLIQUID3541
84126-370-24VICKS ZzzQuil FREE and CLEARNIGHTTIME SLEEP-AID2 in 1 PACKAGELIQUID21

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 5 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLEDAMZ789 LLC12dd2419-b2e0-5466-e063-6394a90a42212026-01-07WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE 50mgDIPHENHYDRAMINE HYDROCHLORIDE 50MGAMZ789 LLCaf0b1b08-e269-6399-e053-2a95a90ac12d2026-01-07WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEProdose, Inc.3b1ea33b-8460-31cf-e063-6394a90a55342025-12-31WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDEPIONEER LIFE SCIENCES, LLCc1dab616-c3ff-4d0a-be13-e8dc6b1a26cc2025-12-29WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa9678fed-bda5-9513-e053-2995a90a25a12025-12-29WarningsExact identifier
application number: M010
sleep patchesSLEEP PATCHESChangsha Maocheng Trading Co., Ltd25eddec9-1713-c2c8-e063-6394a90af02c2025-12-29WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDEPIONEER LIFE SCIENCES, LLC9d6b5ec1-3aa4-4a19-936e-c44b04b2f3fa2025-12-29WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLSafeway, Inc.65d1a199-0a8e-41b1-a767-f16e3f91ac942025-12-26WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLSafeway, Inc.837ddc3a-a8d4-454f-974c-979732cb0a222025-12-26WarningsExact identifier
application number: M010
PharbedrylDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.070e556b-e083-452f-8a7c-aca92470dd612025-12-24WarningsExact identifier
application number: M010
PHARBEDRYLDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.a19f1edc-d2cf-45fc-8233-d882441b02472025-12-24WarningsExact identifier
application number: M010
NIGHT TIME SLEEP-AIDDIPHENHYDRAMINE HCLDiscount Drug Martac1860cb-da95-45bf-9261-19f39c56ddfe2025-12-23WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDENUVICARE LLC963c6925-dfbf-4cdc-8d13-5e10b499c4a92025-12-19WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCL 25 MGNUVICARE LLC85391744-3bf5-428e-a77b-464aa95b3a1a2025-12-19WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY70ec6ac1-2fd8-49dd-9ccb-c16e2f09a2b22025-12-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd337a0e6-09ed-4db0-8883-ec8a5d56bd352025-12-11WarningsExact identifier
application number: M010
Topcare ZZZ SleepDIPHENHYDRAMINE HCLTopco Associates LLC27225d04-6deb-436b-89ea-9842c487292e2025-12-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEHEB91426a5b-dc01-a27b-e053-2a95a90a8ff82025-12-09WarningsExact identifier
application number: M010
Nighttime Sleep Aid, 24-7 Life by 7-ElevenDOXYLAMINE SUCCINATE TABLETLil' Drug Store Products, Inc.457814bc-535c-a136-e063-6394a90af9a42025-12-08WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp97eb3e4d-06b7-49ed-909b-95b523dcce412025-12-05WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN468fa756-1ed6-4652-e063-6294a90a67ea1
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD468fa756-1ed6-4652-e063-6294a90a67ea1
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY468fa756-1ed6-4652-e063-6294a90a67ea1
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY468fa756-1ed6-4652-e063-6294a90a67ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84126-370-24841260370242 BOTTLE, PLASTIC in 1 PACKAGE (84126-370-24) / 354 mL in 1 BOTTLE, PLASTIC2026-02-03NoNoCurrent