FDA.reportPublic FDA data

ZzzQuil

Product NDC
37000-500
11-digit product format
370000500
Labeler code
37000
Product ID
37000-500_5ce1380a-516d-0f76-e063-6294a90a0af1
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
2011-12-08
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
ZzzQuil
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-500-012024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-012024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-062024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-062024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-082024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-082024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-122024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-122024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-242024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-242024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-362024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-362024-01-30ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-062021-02-12ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-062021-02-12ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-122021-02-12ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-122021-02-12ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-242021-02-12ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-242021-02-12ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-362021-02-12ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-362021-02-12ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-062021-01-29ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-062021-01-29ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-122021-01-29ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-122021-01-29ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-242021-01-29ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-242021-01-29ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-362021-01-29ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-362021-01-29ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-500-01ZzzQuilNighttime Sleep-Aid30 mL in 1 BOTTLE, PLASTICLIQUID3021
37000-500-06ZzzQuilNighttime Sleep-Aid177 mL in 1 BOTTLE, PLASTICLIQUID17721
37000-500-08ZzzQuilNighttime Sleep-Aid30 mL in 1 BOTTLE, PLASTICLIQUID3021
37000-500-08ZzzQuilNighttime Sleep-Aid8 in 1 PACKAGE, COMBINATIONLIQUID821
37000-500-12ZzzQuilNighttime Sleep-Aid354 mL in 1 BOTTLE, PLASTICLIQUID35421
37000-500-24ZzzQuilNighttime Sleep-Aid2 in 1 PACKAGE, COMBINATIONLIQUID221
37000-500-36ZzzQuilNighttime Sleep-Aid3 in 1 PACKAGE, COMBINATIONLIQUID321
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-500-06ML - Milliliter37000-5007c7ff596-24c8-4894-a0c7-9df5bfc3aec612013-03-03
37000-500-12ML - Milliliter37000-500e0b24d7c-6a0a-4407-a48b-cca3d0d3b8a112016-06-14
37000-500-24ML - Milliliter37000-5008581da31-ba83-4caa-828e-148ce4cb05a912017-06-15
37000-500-36ML - Milliliter37000-50048fae6c1-97bf-4d14-aac0-8989228fd3d812017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PROCTER & GAMBLE MANUFACRUING COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-500ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]17Current NDC, Legacy NDC, 7 package rows20241012_e441c952-cd48-4159-ada2-271ca7541600.zip
37000-500VICKS ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, Legacy NDC20240715_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 4 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leader1d73e966-aa4a-40a0-b42a-fda8e500756e2026-03-13WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreensea1b5ec1-3c8e-437d-8e37-f38ab66d9f782026-03-13WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8dc17b5d-1cf7-44d2-9e78-d2c6952c7d202026-03-11WarningsExact identifier
application number: M010
sleep aidDIPHENHYDRAMINE HCLRite Aid Corporationbdfd7d87-2b54-4c29-ba69-aad0fab682e72026-03-11WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWal-Mart Stores Inc5ef35ab9-b6e8-4c88-a623-35ac9d6bd3592026-03-05WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLWALMART INC. (see also Equate)84c37f4d-60f6-490e-ba8b-47d1257fa6f82026-02-13WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLP & L Development, LLC59c063ad-6ea3-4f1d-a20e-5e5e062a90982026-02-10WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLWinCo Foods, LLCf446e56f-c664-4092-8712-aa3f204172f82026-02-02WarningsExact identifier
application number: M010
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLCd805fab3-9dca-497f-bdc6-c8a7b17361092026-01-27WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0e45d0e8-3741-7cee-e063-6394a90a2de52026-01-27WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd335b09c6-ee5d-ebdf-e063-6294a90abd122026-01-27WarningsExact identifier
application number: M010
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd32033991-a4f0-f767-e063-6394a90a0b062026-01-27WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Inc90506598-046f-48d3-b8f5-d6ead03338122026-01-27WarningsExact identifier
application number: M010
DORMMY-LONDIPHENHYDRAMINE HYDROCHLORIDEHaendel Farma, S.A. de C.V.562db961-83cb-4b74-9f34-fecee2c1be172026-01-27WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLBetter Living Brands, LLCdec955d3-817d-454f-b146-9a631e908dbc2026-01-27WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEProdose, Inc.c4bc3efd-8ca8-22fe-e053-2a95a90aed452026-01-26WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANYf000d0b5-8ee8-4db0-99fe-aae5ed20c98e2026-01-19WarningsExact identifier
application number: M010
Unisom SleepMinis Nighttime Sleep-AidDIPHENHYDRAMINE HCLChattem, Inc.a9a44c2f-65eb-4a5a-9e72-43652dce57f72026-01-14WarningsExact identifier
application number: M010
Unisom SleepMelts Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.9105f4f1-7f94-408d-a025-83afb68dc9f02026-01-14WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC462ca6cd-8eec-09df-e063-6294a90ac8802026-01-13WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNe441c952-cd48-4159-ada2-271ca754160021
1248356ZzzQuil NIGHTTIME SLEEP-AID 50 MG in 30 mL Oral SolutionPSNe441c952-cd48-4159-ada2-271ca754160021
1248356diphenhydramine hydrochloride 1.67 MG/ML Oral Solution [Zzzquil]SBDe441c952-cd48-4159-ada2-271ca754160021
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDe441c952-cd48-4159-ada2-271ca754160021
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYe441c952-cd48-4159-ada2-271ca754160021
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYe441c952-cd48-4159-ada2-271ca754160021
1248356Zzzquil 1.67 MG/ML Oral SolutionSYe441c952-cd48-4159-ada2-271ca754160021
1248356Zzzquil 50 MG per 30 ML Oral SolutionSYe441c952-cd48-4159-ada2-271ca754160021
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
37000-500-013700005000130 mL in 1 BOTTLE, PLASTIC (37000-500-01) 30 ml2023-01-25NoNoCurrent
37000-500-0437000050004118 mL in 1 BOTTLE, PLASTIC (37000-500-04) 118 ml2022-06-070000-00-00NoNoCurrent
37000-500-0637000050006177 mL in 1 BOTTLE, PLASTIC (37000-500-06) 177 ml2011-12-080000-00-00NoNoCurrent
37000-500-08370000500088 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (37000-500-08) / 30 mL in 1 BOTTLE, PLASTIC2023-01-25NoNoCurrent
37000-500-1237000050012354 mL in 1 BOTTLE, PLASTIC (37000-500-12) 354 ml2011-12-080000-00-00NoNoCurrent
37000-500-24370000500242 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (37000-500-24) / 354 mL in 1 BOTTLE, PLASTIC (37000-500-12) 2011-12-080000-00-00NoNoCurrent
37000-500-36370000500363 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (37000-500-36) / 354 mL in 1 BOTTLE, PLASTIC (37000-500-12) 2011-12-080000-00-00NoNoCurrent