ZzzQuil

Product NDC
69423-965
11-digit product format
694230965
Labeler code
69423
Product ID
69423-965_e4f3b6f0-716e-9e10-e053-2995a90a8fe3
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M010
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-04-19
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69423-965DDiscontinued by firm2026-10-12
excluded packagepackage69423-96569423-965-12DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-965-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69423-965-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69423-965-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69423-965-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69423-965-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69423-965-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69423-965-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69423-965-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69423-965-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69423-965-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69423-965-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69423-965-12557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 11 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENHYDRAMINE HCLH E Bd5189048-5eed-4ec4-8c4a-4a167728c4e72024-10-16WarningsExact identifier
application number: M010
berkley and jensen sleep aidDIPHENHYDRAMINE HCLBJWCe31917a1-e72d-4f71-893f-43046169a32d2024-10-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association5fab9bd4-66d7-4356-a778-8900b2e270e22024-10-11WarningsExact identifier
application number: M010
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)5b005bfc-f588-4abc-8bb1-4691b40448cd2024-10-07WarningsExact identifier
application number: M010
SominexDIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.f70ce1a6-c334-025e-e053-6294a90ae53f2024-10-03WarningsExact identifier
application number: M010
meijer NIGHTTIME Sleep Aid CAPLETDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1c2b57b3-92cb-256b-e063-6394a90ad41b2024-09-09WarningsExact identifier
application number: M010
Up and Up Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETarget Corporation0ab5a374-d565-4385-bee3-538a8f09b19e2024-08-15WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.8d985ad7-71b9-493f-9b9a-d6ef280f72dd2024-08-12WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.3618eb73-6929-4ca5-833d-265b006f15f92024-08-12WarningsExact identifier
application number: M010
careone nighttime sleep aidDIPHENHYDRAMINE HYDROCHLORIDEAmerican Sales Company14803f99-52c7-4324-b64c-9719061447392024-07-17WarningsExact identifier
application number: M010
Betr sleep aidDIPHENHYDRAMINE HYDROCHLORIDELive Betr LLC8c2d5514-62c1-4e98-8412-20534365b9342024-07-17WarningsExact identifier
application number: M010
topcare sleep aid nighttimeDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC30284271-0411-4abf-bc62-d956dc7944322024-07-17WarningsExact identifier
application number: M010
dg health sleep aidDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp Inc038c1b4e-43f5-4370-896b-97da1b0a89ca2024-07-17WarningsExact identifier
application number: M010
good sense nighttime sleep aidDIPHENHYDRAMINE HYDROCHLORIDEL. Perrigo Companyba2adc30-0301-4d53-bce6-fc8b7e34b0762024-07-10WarningsExact identifier
application number: M010
Sleep AidSLEEP AIDGood Sensec1481fad-9b32-4f84-8f03-4b4fa5edc8662024-06-18WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)29b49616-ee5a-4574-81f1-0052addb8f662024-04-22WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)b8757d18-6c7d-45de-925a-e2814625f7492024-04-22WarningsExact identifier
application number: M010
EZ Nite SleepDIPHENHYRAMINE HYDROCHLORIDEKROGER COMPANY0fec16a4-b4eb-8f8f-e063-6394a90a73272024-04-17WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLCVS Pharmacydb951d14-ba8b-4d56-8264-2b8ce84a854c2024-03-07WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)e0da439f-7e23-4e60-8d16-b607aa41ed172024-02-28WarningsExact identifier
application number: M010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-965-1269423096512354 mL in 1 BOTTLE, PLASTIC (69423-965-12) 354 ml2021-04-190000-00-00NoNoCurrent