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

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 packagepackage0113-01860113-0186-30DDiscontinued by firm2026-08-10

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 · 10 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…

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 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
1248354Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
164200a9-b1f8-44c9-8598-a7dff5020e9dAvailable 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
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

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 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