FDA.reportPublic FDA data

ZzzQuil

Product NDC
66715-9746
11-digit product format
667159746
Labeler code
66715
Product ID
66715-9746_2733bf33-a0be-9d8a-e063-6294a90a26ad
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-23
Marketing end
2027-05-23
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/21
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/21

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049909Internal RxNorm lookup
1248360Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b2777be-85d4-443d-b65f-6750e0ba97baAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-9746-1ZzzQuil1 in 1 CARTONCAPSULE, LIQUID FILLED17
66715-9746-1ZzzQuil2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9746ZZZQUIL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIL' DRUG STORE PRODUCTS, INC.]7Current NDC, Legacy NDC, 2 package rows20241120_0b2777be-85d4-443d-b65f-6750e0ba97ba.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 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
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN0b2777be-85d4-443d-b65f-6750e0ba97ba7
1248360ZzzQuil NIghttime Sleep Aid 25 MG Oral CapsulePSN0b2777be-85d4-443d-b65f-6750e0ba97ba7
1248360diphenhydramine hydrochloride 25 MG Oral Capsule [Zzzquil]SBD0b2777be-85d4-443d-b65f-6750e0ba97ba7
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD0b2777be-85d4-443d-b65f-6750e0ba97ba7
1248360Zzzquil 25 MG Oral CapsuleSY0b2777be-85d4-443d-b65f-6750e0ba97ba7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9746-1667159746011 BLISTER PACK in 1 CARTON (66715-9746-1) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2018-12-312027-05-23NoNoCurrent