careone nighttime sleep aid

Product NDC
41520-431
11-digit product format
415200431
Labeler code
41520
Product ID
41520-431_3c6e54e3-91a1-4696-ab6f-3b049193ab8d
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Sales Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-04-13
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
careone 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
41520-431-62careone nighttime sleep aid12 in 1 CARTONTABLET, FILM COATED125
41520-431-62careone nighttime sleep aid2 in 1 BLISTER PACKTABLET, FILM COATED25
41520-431-67careone nighttime sleep aid2 in 1 BLISTER PACKTABLET, FILM COATED25
41520-431-67careone nighttime sleep aid24 in 1 CARTONTABLET, FILM COATED245

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-431CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 4 package rows20240724_14803f99-52c7-4324-b64c-971906144739.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN14803f99-52c7-4324-b64c-9719061447395
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD14803f99-52c7-4324-b64c-9719061447395

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-431-624152004316212 BLISTER PACK in 1 CARTON (41520-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2004-04-130000-00-00NoNoCurrent
41520-431-674152004316724 BLISTER PACK in 1 CARTON (41520-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2008-08-080000-00-00NoNoCurrent