FDA.reportPublic FDA data

good sense sleep time

Product NDC
0113-0052
Requested package NDC
0113-0052-53
11-digit product format
001130052
Labeler code
0113
Product ID
0113-0052_e2346394-7edc-4922-89c5-6c9da56a8fec
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
L. Perrigo Company
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-06
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage0113-00520113-0052-53DDiscontinued by firm2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0113-00520113-0052-53DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0113-00520113-0052-53DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0052-53EA - Each0113-005282161348-e71e-448d-b6c1-bf13e6fc412f12018-06-11
0113-0052-67EA - Each0113-005289b944e1-a2fc-47bb-9ca6-6dfb2e67697012023-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40GOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]2
GELATININACTIVE INGREDIENT2G86QN327LGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0052GOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]7Legacy NDC20241106_c6d2d1bc-fe84-4886-bcd4-ae88dd7e5e42.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0052-53001130052536 BLISTER PACK in 1 CARTON (0113-0052-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK6 blister pack2014-02-060000-00-00NoNoCurrent