FDA.reportPublic FDA data

Topcare ZZZ Sleep

Product NDC
36800-200
Requested package NDC
36800-200-34
11-digit product format
368000200
Labeler code
36800
Product ID
36800-200_b2891495-9d6a-4173-bf1b-a94d7747370c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Topco Associates LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-20
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
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-20036800-200-34DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare ZZZ Sleep
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1248354Internal RxNorm lookup
1437306Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
27225d04-6deb-436b-89ea-9842c487292eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-200-30Topcare ZZZ Sleep177 mL in 1 BOTTLESOLUTION1779
36800-200-34Topcare ZZZ Sleep236 mL in 1 BOTTLESOLUTION2369
36800-200-40Topcare ZZZ Sleep355 mL in 1 BOTTLESOLUTION3559
36800-200-50Topcare ZZZ Sleep355 mL in 1 BOTTLESOLUTION3559
36800-200-50Topcare ZZZ Sleep2 in 1 PACKAGESOLUTION29

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-200TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 5 package rows20241018_27225d04-6deb-436b-89ea-9842c487292e.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 1 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidDIPHENHYDRAMINE HCLDOLGENCORP, LLC2bb3016a-2e03-43fe-a655-45d4ec872c792026-08-05WarningsExact identifier
application number: M010
Sleep TabsDIPHENHYDRAMINE HCLMajor Pharmaceuticalsff8b7346-5be5-4e76-9ee2-d52fab66f6c52026-08-03WarningsExact identifier
application number: M010
MantraMANTRA SLEEP AID WILD CHERRYMOREMED INC.316d11fe-a173-a1dd-e063-6394a90af4992026-07-27WarningsExact identifier
application number: M010
Wal Som Nighttime Sleep AidDIPHENHYDRAMINE HCLWalgreensff475a69-dbb2-40a9-b7f4-9c7b7e975d192026-07-23WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporation336ac29d-db24-44da-a299-5a4793ae8f6a2026-07-21WarningsExact identifier
application number: M010
Best Choice Childrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLBEST CHOICE (VALU MERCHANDISERS COMPANY)9bf2d698-8394-46c3-b7a9-e99ab6bb88e42026-07-17WarningsExact identifier
application number: M010
ADWE dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDERARITAN PHARMACEUTICALS INCea3a51af-3025-497f-8cd7-e99391b0d06f2026-07-17WarningsExact identifier
application number: M010
nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLCa8056e5f-e9d8-4555-9212-bf1fa3c154392026-07-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAmerisource Bergen147adc14-ca7c-45f5-9925-ea569edbfe962026-07-09WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCL 25 MGHealth Pharma USA LLCd659f747-9790-8bd6-e053-2995a90ae7932026-07-07WarningsExact identifier
application number: M010
PharbedrylDIPHENHYDRAMINE HCLSt. Mary's Medical Park Pharmacy3ef18965-bafb-cc19-e063-6394a90af17d2026-06-29WarningsExact identifier
application number: M010
CalmCo Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC552d0e50-a58c-8e47-e063-6394a90a8f7b2026-06-26WarningsExact identifier
application number: M010
Vicks ZzzQuil Night PainDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENThe Procter & Gamble Manufacturing Companya7cf8e2e-7aac-a1fa-e053-2a95a90a561a2026-06-26WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLBi-Mart1b40e794-089f-4546-8f8d-ba7016cd4e7f2026-06-22WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLRite Aid Corporation1a5668df-2bbc-4724-af39-19d30a8920f32026-06-22WarningsExact identifier
application number: M010
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLC9f1e2e1f-d3e8-4c8a-9e3e-c2ab9e4c79e82026-06-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTopco Associates, LLC57a81e24-ef0d-4143-b266-71e2d4be76172026-06-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCVS Pharmacy3710254e-6c3c-4044-9694-59703274cd0f2026-06-15WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLWal-Mart Stores Inccfddfdeb-701f-452d-876d-8003e6fcefe32026-06-15WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLFamily Dollar Services Inc2d63400b-43ae-4dd2-b917-3f65e02366b42026-06-08WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN27225d04-6deb-436b-89ea-9842c487292e9
1437306ZZZ Sleep 50 MG in 30 mL Oral SolutionPSN27225d04-6deb-436b-89ea-9842c487292e9
1437306diphenhydramine hydrochloride 1.67 MG/ML Oral Solution [ZZZ Sleep]SBD27225d04-6deb-436b-89ea-9842c487292e9
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD27225d04-6deb-436b-89ea-9842c487292e9
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY27225d04-6deb-436b-89ea-9842c487292e9
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY27225d04-6deb-436b-89ea-9842c487292e9
1437306ZZZ Sleep 1.67 MG/ML Oral SolutionSY27225d04-6deb-436b-89ea-9842c487292e9
1437306ZZZ Sleep 50 MG per 30 ML Oral SolutionSY27225d04-6deb-436b-89ea-9842c487292e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-200-3436800020034236 mL in 1 BOTTLE (36800-200-34) 236 ml2013-09-190000-00-00NoNoCurrent