FDA.reportPublic FDA data

VICKS ZzzQuil FREE and CLEAR

Product NDC
84126-370
11-digit product format
841260370
Labeler code
84126
Product ID
84126-370_468fa4cc-b9c8-c51c-e063-6394a90a2126
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VICKS ZzzQuil FREE and CLEAR
Brand name suffix
NIGHTTIME SLEEP-AID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354

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

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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-370-1284126037012354 mL in 1 BOTTLE, PLASTIC (84126-370-12) 354 ml2026-02-03NoNoCurrent
84126-370-24841260370242 BOTTLE, PLASTIC in 1 PACKAGE (84126-370-24) / 354 mL in 1 BOTTLE, PLASTIC2026-02-03NoNoCurrent