good sense nighttime sleep aid

Product NDC
0113-0431
11-digit product format
001130431
Labeler code
0113
Product ID
0113-0431_70250c98-1eb2-4522-bdc6-7ce5a1468fda
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-04-25
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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 nighttime sleep aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0431-62good sense nighttime sleep aid12 in 1 CARTONTABLET, FILM COATED125
0113-0431-62good sense nighttime sleep aid2 in 1 BLISTER PACKTABLET, FILM COATED25
0113-0431-68good sense nighttime sleep aid2 in 1 BLISTER PACKTABLET, FILM COATED25
0113-0431-68good sense nighttime sleep aid18 in 1 CARTONTABLET, FILM COATED185
0113-0431-78good sense nighttime sleep aid100 in 1 BOTTLETABLET, FILM COATED1005
0113-0431-78good sense nighttime sleep aid1 in 1 CARTONTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0431-62EA - Each0113-04319649502f-c6fa-4d7d-a6f7-a5202e5cda0e12012-07-24
0113-0431-78EA - Each0113-0431f5f22766-f73c-453c-bdb9-0283651b882912024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40GOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0431GOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 6 package rows20240711_ba2adc30-0301-4d53-bce6-fc8b7e34b076.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNba2adc30-0301-4d53-bce6-fc8b7e34b0765
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDba2adc30-0301-4d53-bce6-fc8b7e34b0765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0431-620011304316212 BLISTER PACK in 1 CARTON (0113-0431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2001-04-250000-00-00NoNoCurrent
0113-0431-680011304316818 BLISTER PACK in 1 CARTON (0113-0431-68) > 2 TABLET, FILM COATED in 1 BLISTER PACK18 blister pack2019-05-210000-00-00NoNoCurrent
0113-0431-78001130431781 BOTTLE in 1 CARTON (0113-0431-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-290000-00-00NoNoCurrent