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 4 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI6c9b7576-428a-4884-8331-bb312c9046bd2026-04-01WarningsExact identifier
application number: M010
Calmco Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC471d4c70-813a-19de-e063-6394a90aeb252026-03-31WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLThe Kroger Co.0db543bb-c6c3-4370-a70c-e1652781fd7d2026-03-25WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCL 50MGGrocery Outlet57a751e9-d8b6-4527-8537-bc4be718f5ec2026-03-17WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreen Companydf7a43d1-83a7-4e86-baef-4b9d1ebf0dbb2026-03-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEGrocery Outlet, Inc.4454df6a-931f-3f03-e063-6294a90afe732026-03-14WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leader1d73e966-aa4a-40a0-b42a-fda8e500756e2026-03-13WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreensea1b5ec1-3c8e-437d-8e37-f38ab66d9f782026-03-13WarningsExact identifier
application number: M010
ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyad4babdb-d98d-420e-b8b0-9a5368c89a442026-03-12WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8dc17b5d-1cf7-44d2-9e78-d2c6952c7d202026-03-11WarningsExact identifier
application number: M010
sleep aidDIPHENHYDRAMINE HCLRite Aid Corporationbdfd7d87-2b54-4c29-ba69-aad0fab682e72026-03-11WarningsExact identifier
application number: M010
ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company1d608c94-1651-f318-e063-6294a90aa11e2026-03-05WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWal-Mart Stores Inc5ef35ab9-b6e8-4c88-a623-35ac9d6bd3592026-03-05WarningsExact identifier
application number: M010
ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companye441c952-cd48-4159-ada2-271ca75416002026-02-20WarningsExact identifier
application number: M010
Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVERDIPHENHYDRAMINE HCL, ACETAMINOPHENThe Procter & Gamble Manufacturing Company065d760b-70a5-3e26-e063-6394a90a48cd2026-02-20WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLWALMART INC. (see also Equate)84c37f4d-60f6-490e-ba8b-47d1257fa6f82026-02-13WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLP & L Development, LLC59c063ad-6ea3-4f1d-a20e-5e5e062a90982026-02-10WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLWinCo Foods, LLCf446e56f-c664-4092-8712-aa3f204172f82026-02-02WarningsExact identifier
application number: M010
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLCd805fab3-9dca-497f-bdc6-c8a7b17361092026-01-27WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0e45d0e8-3741-7cee-e063-6394a90a2de52026-01-27WarningsExact 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