Sleep Aid Nighttime

Product NDC
36800-784
11-digit product format
368000784
Labeler code
36800
Product ID
36800-784_fcc77456-2add-4ebd-be0f-e744101db96e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Sleep Aid Nighttime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f1c078d-e537-4ec0-8ae9-54c98282be29Available 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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-784-96Sleep Aid Nighttime96 in 1 BOTTLECAPSULE, LIQUID FILLED964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-784SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 1 package rows20250108_9f1c078d-e537-4ec0-8ae9-54c98282be29.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 12 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline Night Time Sleep AidDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI6d34ee3e-3d61-481e-98d6-acfa066e42472024-10-16WarningsExact identifier
application number: M010
basic care nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLC027de5ea-5c07-4960-8a98-8cf2c0e54a922024-10-16WarningsExact identifier
application number: M010
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-784-963680007849696 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-784-96) 2021-05-010000-00-00NoNoCurrent