FDA.reportPublic FDA data

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 5 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd335b09c6-ee5d-ebdf-e063-6294a90abd122026-01-27WarningsExact identifier
application number: M010
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd32033991-a4f0-f767-e063-6394a90a0b062026-01-27WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Inc90506598-046f-48d3-b8f5-d6ead03338122026-01-27WarningsExact identifier
application number: M010
DORMMY-LONDIPHENHYDRAMINE HYDROCHLORIDEHaendel Farma, S.A. de C.V.562db961-83cb-4b74-9f34-fecee2c1be172026-01-27WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLBetter Living Brands, LLCdec955d3-817d-454f-b146-9a631e908dbc2026-01-27WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEProdose, Inc.c4bc3efd-8ca8-22fe-e053-2a95a90aed452026-01-26WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANYf000d0b5-8ee8-4db0-99fe-aae5ed20c98e2026-01-19WarningsExact identifier
application number: M010
Unisom SleepMinis Nighttime Sleep-AidDIPHENHYDRAMINE HCLChattem, Inc.a9a44c2f-65eb-4a5a-9e72-43652dce57f72026-01-14WarningsExact identifier
application number: M010
Unisom SleepMelts Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.9105f4f1-7f94-408d-a025-83afb68dc9f02026-01-14WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC462ca6cd-8eec-09df-e063-6294a90ac8802026-01-13WarningsExact identifier
application number: M010
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
Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVERDIPHENHYDRAMINE HCL, ACETAMINOPHENThe Procter & Gamble Manufacturing Company47683352-c3c7-13cd-e063-6294a90af6bf2026-01-02WarningsExact 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

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