ZzzQuil

Product NDC
37000-500
11-digit product format
370000500
Labeler code
37000
Product ID
37000-500_4b456ea0-a1c4-e3f2-e063-6294a90ae679
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

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354, 1248356

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-500-012024-01-30C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-062024-01-30C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-082024-01-30C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-122024-01-30C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-242024-01-30C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-362024-01-30C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-062021-02-12C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-122021-02-12C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-242021-02-12C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-362021-02-12C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-062021-01-29C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-122021-01-29C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-242021-01-29C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ NIGHTTIME SLEEP-AID WARMING BERRY
37000-500-362021-01-29C16284748780-1ba0f9c33-515f-a910-e053-dadaa90a0b85ZzzQuil™ 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

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