FDA.reportPublic FDA data

ZzzQuil

Product NDC
37000-501
Requested package NDC
37000-501-08
11-digit product format
370000501
Labeler code
37000
Product ID
37000-501_5ce13020-78b5-38ca-e063-6394a90a6c58
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, GELATIN COATED
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
25 mg/1
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 HYDROCHLORIDE25 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-501-02ZzzQuilNighttime Sleep-Aid2 in 1 BLISTER PACKCAPSULE, GELATIN COATED224
37000-501-08ZzzQuilNighttime Sleep-Aid8 in 1 CARTONCAPSULE, GELATIN COATED824
37000-501-08ZzzQuilNighttime Sleep-Aid2 in 1 BLISTER PACKCAPSULE, GELATIN COATED224
37000-501-12ZzzQuilNighttime Sleep-Aid6 in 1 CARTONCAPSULE, GELATIN COATED624
37000-501-12ZzzQuilNighttime Sleep-Aid2 in 1 BLISTER PACKCAPSULE, GELATIN COATED224
37000-501-24ZzzQuilNighttime Sleep-Aid2 in 1 BLISTER PACKCAPSULE, GELATIN COATED224
37000-501-24ZzzQuilNighttime Sleep-Aid12 in 1 CARTONCAPSULE, GELATIN COATED1224
37000-501-48ZzzQuilNighttime Sleep-Aid24 in 1 CARTONCAPSULE, GELATIN COATED2424
37000-501-48ZzzQuilNighttime Sleep-Aid2 in 1 BLISTER PACKCAPSULE, GELATIN COATED224
37000-501-72ZzzQuilNighttime Sleep-Aid2 in 1 BLISTER PACKCAPSULE, GELATIN COATED224
37000-501-72ZzzQuilNighttime Sleep-Aid36 in 1 CARTONCAPSULE, GELATIN COATED3624
37000-501-96ZzzQuilNighttime Sleep-Aid2 in 1 CELLO PACKCAPSULE, GELATIN COATED224
37000-501-96ZzzQuilNighttime Sleep-Aid24 in 1 CARTONCAPSULE, GELATIN COATED2424

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-501-12EA - Each37000-5012c431dae-d36f-474d-9608-04ebde59634312017-06-15
37000-501-24EA - Each37000-501288b7430-60a0-4157-85bb-a5b2c6cc038012017-06-15
37000-501-48EA - Each37000-501a4ec1a0c-1100-4198-abcf-246fe803823d12017-06-15
37000-501-72EA - Each37000-501a8709c2e-1a82-47ca-9a7a-0272e149fa7b12017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [PROCTER & GAMBLE MANUFACTURING COMPANY]2
DiphenhydramineACTIVE MOIETY8GTS82S83MZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [PROCTER & GAMBLE MANUFACTURING COMPANY]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [PROCTER & GAMBLE MANUFACTURING COMPANY]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [PROCTER & GAMBLE MANUFACTURING COMPANY]2
gelatinINACTIVE INGREDIENT2G86QN327LZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [PROCTER & GAMBLE MANUFACTURING COMPANY]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [PROCTER & GAMBLE MANUFACTURING COMPANY]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [PROCTER & GAMBLE MANUFACTURING COMPANY]2
sorbitolINACTIVE INGREDIENT506T60A25RZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [PROCTER & GAMBLE MANUFACTURING COMPANY]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [PROCTER & GAMBLE MANUFACTURING COMPANY]2
waterINACTIVE INGREDIENT059QF0KO0RZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [PROCTER & GAMBLE MANUFACTURING COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-501ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]21Current NDC, Legacy NDC, 13 package rows20241012_ad4babdb-d98d-420e-b8b0-9a5368c89a44.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 1 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
application number: M010
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationedfe32b5-9213-4350-9508-2530ee26c5d52026-09-02WarningsExact identifier
application number: M010
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
application number: M010
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsExact identifier
application number: M010
Wal Som Nighttime Sleep Aid NighttimeDIPHENHYDRAMINE HCLWalgreens4cb0f9ab-1be1-4b41-a233-bbd0327036e22026-08-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEKroger514aa6b5-c33b-494c-e063-6294a90a7ace2026-08-27WarningsExact identifier
application number: M010
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEHyVee Inc496ce4ba-08a9-ee99-e063-6294a90ac9a72026-08-21WarningsExact identifier
application number: M010
CVS Nighttime Childrens Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACYd66b1a2e-49b6-473b-acec-2694c73ce8b42026-08-19WarningsExact identifier
application number: M010
CVS Childrens Nighttime Multi Symptom ColdACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d2026-08-19WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsExact identifier
application number: M010
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsExact identifier
application number: M010
CVS Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENCVS PHARMACY333e170e-52cd-4218-8d15-0bf3c5c75cb92026-08-14WarningsExact identifier
application number: M010
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsExact identifier
application number: M010
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
application number: M010
CVS Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed32026-08-14WarningsExact identifier
application number: M010
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLC6fb6cfde-30a6-419c-973d-8abdc72611ed2026-08-07WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNad4babdb-d98d-420e-b8b0-9a5368c89a4424
1248360ZzzQuil NIghttime Sleep Aid 25 MG Oral CapsulePSNad4babdb-d98d-420e-b8b0-9a5368c89a4424
1248360diphenhydramine hydrochloride 25 MG Oral Capsule [Zzzquil]SBDad4babdb-d98d-420e-b8b0-9a5368c89a4424
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDad4babdb-d98d-420e-b8b0-9a5368c89a4424
1248360Zzzquil 25 MG Oral CapsuleSYad4babdb-d98d-420e-b8b0-9a5368c89a4424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-501-08370000501088 BLISTER PACK in 1 CARTON (37000-501-08) / 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK8 blister pack2022-06-070000-00-00NoNoCurrent