FDA.reportPublic FDA data

Simply Sleep

Product NDC
50580-843
11-digit product format
505800843
Labeler code
50580
Product ID
50580-843_369b679c-4911-8ef8-e063-6394a90abd0a
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-02-01
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
Simply Sleep
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630, 1092466

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-843-112024-02-01C16284748780-11030e365-02c1-111a-e063-dadaa90a10e2Simply Sleep
50580-843-122024-02-01C16284748780-11030e365-02c1-111a-e063-dadaa90a10e2Simply Sleep
50580-843-112024-01-30C16284748780-11030e365-02c1-111a-e063-dadaa90a10e2Simply Sleep
50580-843-122024-01-30C16284748780-11030e365-02c1-111a-e063-dadaa90a10e2Simply Sleep

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-843-11Simply Sleep12 in 1 BLISTER PACKTABLET, FILM COATED1211
50580-843-11Simply Sleep2 in 1 CARTONTABLET, FILM COATED211
50580-843-12Simply Sleep100 in 1 BOTTLETABLET, FILM COATED10011
50580-843-12Simply Sleep1 in 1 CARTONTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-843-12EA - Each50580-843d51b8f92-9e03-4b6b-98d1-9abc4eea6c8c12016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
diphenhydramineACTIVE MOIETY8GTS82S83MSIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-843SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 4 package rows20241109_37c606b0-04d5-49f0-886a-3ee2c9b0e9cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN37c606b0-04d5-49f0-886a-3ee2c9b0e9cc11
1092466Simply Sleep 25 MG Oral TabletPSN37c606b0-04d5-49f0-886a-3ee2c9b0e9cc11
1092466diphenhydramine hydrochloride 25 MG Oral Tablet [Simply Sleep]SBD37c606b0-04d5-49f0-886a-3ee2c9b0e9cc11
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD37c606b0-04d5-49f0-886a-3ee2c9b0e9cc11
1092466Simply Sleep 25 MG Oral TabletSY37c606b0-04d5-49f0-886a-3ee2c9b0e9cc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-843-115058008431112 in 1 BLISTER PACKHistorical
50580-843-12505800843121 BOTTLE in 1 CARTON (50580-843-12) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-04-100000-00-00NoNoCurrent