FDA.reportPublic FDA data

topcare sleep aid

Product NDC
36800-431
11-digit product format
368000431
Labeler code
36800
Product ID
36800-431_b0cba6ea-b6ae-42a0-aaae-055d03fb8254
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-09-11
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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
topcare sleep aid
Brand name suffix
nighttime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30284271-0411-4abf-bc62-d956dc794432Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-431-622024-01-30C16284748780-11030e365-6e3b-111a-e063-dadaa90a10e2Topco Associates LLC. Nighttime Sleep Aid Drug Facts
36800-431-672024-01-30C16284748780-11030e365-6e3b-111a-e063-dadaa90a10e2Topco Associates LLC. Nighttime Sleep Aid Drug Facts
36800-431-782024-01-30C16284748780-11030e365-6e3b-111a-e063-dadaa90a10e2Topco Associates LLC. Nighttime Sleep Aid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-431-62topcare sleep aidnighttime12 in 1 CARTONTABLET, FILM COATED128
36800-431-62topcare sleep aidnighttime2 in 1 BLISTER PACKTABLET, FILM COATED28
36800-431-67topcare sleep aidnighttime24 in 1 CARTONTABLET, FILM COATED248
36800-431-67topcare sleep aidnighttime2 in 1 BLISTER PACKTABLET, FILM COATED28
36800-431-78topcare sleep aidnighttime100 in 1 BOTTLETABLET, FILM COATED1008
36800-431-78topcare sleep aidnighttime1 in 1 CARTONTABLET, FILM COATED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-431-62EA - Each36800-431449e653e-75b4-4421-9fa6-f9eda8dbd3ad12012-07-24
36800-431-67EA - Each36800-431b240e965-3ece-4b7f-b6e7-8c7315ba1e6612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40TOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-431TOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 6 package rows20240724_30284271-0411-4abf-bc62-d956dc794432.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 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Sleep AidDIPHENHYDRAMINE HCLWal-Mart Stores Inc5ef35ab9-b6e8-4c88-a623-35ac9d6bd3592026-03-05WarningsExact 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN30284271-0411-4abf-bc62-d956dc7944328
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD30284271-0411-4abf-bc62-d956dc7944328

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-431-623680004316212 BLISTER PACK in 1 CARTON (36800-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2001-09-110000-00-00NoNoCurrent
36800-431-673680004316724 BLISTER PACK in 1 CARTON (36800-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2004-01-270000-00-00NoNoCurrent
36800-431-78368000431781 BOTTLE in 1 CARTON (36800-431-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-09-130000-00-00NoNoCurrent