FDA.reportPublic FDA data

Good Sense Sleep Time

Product NDC
0113-0186
11-digit product format
001130186
Labeler code
0113
Product ID
0113-0186_11d3cf0a-5b3d-4dcc-b77d-609b81abfdd6
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
L. Perrigo Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-02
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
Good Sense Sleep Time
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354

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
0113-0186-30Good Sense Sleep Time177 mL in 1 BOTTLESOLUTION1775
0113-0186-40Good Sense Sleep Time355 mL in 1 BOTTLESOLUTION3555

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0186-30ML - Milliliter0113-018645611dc5-e647-4245-ba79-4b697cad788f12018-02-20
0113-0186-40ML - Milliliter0113-0186e863ac7e-9fa3-4e88-bc49-04d37878478012018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40GOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0186GOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 2 package rows20241018_164200a9-b1f8-44c9-8598-a7dff5020e9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN164200a9-b1f8-44c9-8598-a7dff5020e9d5
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD164200a9-b1f8-44c9-8598-a7dff5020e9d5
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY164200a9-b1f8-44c9-8598-a7dff5020e9d5
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY164200a9-b1f8-44c9-8598-a7dff5020e9d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0186-3000113018630177 mL in 1 BOTTLE (0113-0186-30) 177 ml2013-07-020000-00-00NoNoCurrent
0113-0186-4000113018640355 mL in 1 BOTTLE (0113-0186-40) 355 ml2013-07-020000-00-00NoNoCurrent