sleep aid

Product NDC
56062-431
11-digit product format
560620431
Labeler code
56062
Product ID
56062-431_34423ebd-38fa-4a4f-bda4-c87cab413163
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Publix Super Markets Inc
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-07-24
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
56062-431-622024-01-30C16284748780-11030e365-35e4-111a-e063-dadaa90a10e2Publix Super Markets, Inc. Sleep Aid Drug Facts
56062-431-782024-01-30C16284748780-11030e365-35e4-111a-e063-dadaa90a10e2Publix Super Markets, Inc. Sleep Aid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-431-62sleep aid12 in 1 CARTONTABLET, FILM COATED125
56062-431-62sleep aid2 in 1 BLISTER PACKTABLET, FILM COATED25
56062-431-78sleep aid1 in 1 CARTONTABLET, FILM COATED15
56062-431-78sleep aid100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-431SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [PUBLIX SUPER MARKETS INC]5Current NDC, Legacy NDC, 4 package rows20240724_3e587ea9-2f0b-4d39-ad23-67436804fe48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3e587ea9-2f0b-4d39-ad23-67436804fe485
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3e587ea9-2f0b-4d39-ad23-67436804fe485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-431-625606204316212 BLISTER PACK in 1 CARTON (56062-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2002-05-090000-00-00NoNoCurrent
56062-431-78560620431781 BOTTLE in 1 CARTON (56062-431-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2011-08-290000-00-00NoNoCurrent