Topcare ZZZ Sleep

Product NDC
36800-200
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

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 Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354, 1437306

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

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
36800-200-3036800020030177 mL in 1 BOTTLE (36800-200-30) 177 ml2013-08-230000-00-00NoNoCurrent
36800-200-3436800020034236 mL in 1 BOTTLE (36800-200-34) 236 ml2013-09-190000-00-00NoNoCurrent
36800-200-4036800020040355 mL in 1 BOTTLE (36800-200-40) 355 ml2013-08-200000-00-00NoNoCurrent
36800-200-50368000200502 BOTTLE in 1 PACKAGE (36800-200-50) / 355 mL in 1 BOTTLE2 bottle2013-08-200000-00-00NoNoCurrent