FDA.reportPublic FDA data

Sleep II

Product NDC
0363-0189
11-digit product format
003630189
Labeler code
0363
Product ID
0363-0189_f9530ae2-f2e6-4caa-8f2f-4840b31d5ef8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Walgreen Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-04-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep II
Brand name suffix
Nighttime Sleep Aid
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0189-08Sleep IINighttime Sleep Aid8 in 1 BLISTER PACKTABLET827
0363-0189-08Sleep IINighttime Sleep Aid3 in 1 CARTONTABLET327
0363-0189-21Sleep IINighttime Sleep Aid2 in 1 CARTONTABLET227
0363-0189-21Sleep IINighttime Sleep Aid8 in 1 BLISTER PACKTABLET827
0363-0189-23Sleep IINighttime Sleep Aid1 in 1 CARTONTABLET127
0363-0189-23Sleep IINighttime Sleep Aid72 in 1 BOTTLE, PLASTICTABLET7227
0363-0189-46Sleep IINighttime Sleep Aid1 in 1 CARTONTABLET127
0363-0189-46Sleep IINighttime Sleep Aid96 in 1 BOTTLE, PLASTICTABLET9627

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0189-08EA - Each0363-0189e141d3ae-5829-4cf3-abad-79231269eebc12014-10-03
0363-0189-21EA - Each0363-01895cb420bd-7349-4038-b375-577cd70a209112012-07-24
0363-0189-23EA - Each0363-0189d89ac9ee-d733-4a6c-a9f7-49179f9daa7c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]10
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]10
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0189SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN COMPANY]26Current NDC, Legacy NDC, 8 package rows20250512_ed864c84-a430-4ca8-87e8-04f1c1df538b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNed864c84-a430-4ca8-87e8-04f1c1df538b27
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDed864c84-a430-4ca8-87e8-04f1c1df538b27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0189-08003630189083 BLISTER PACK in 1 CARTON (0363-0189-08) > 8 TABLET in 1 BLISTER PACK3 blister pack1990-04-102022-08-14NoNoCurrent
0363-0189-21003630189212 in 1 CARTONHistorical
0363-0189-23003630189231 BOTTLE, PLASTIC in 1 CARTON (0363-0189-23) > 72 TABLET in 1 BOTTLE, PLASTIC1990-04-102022-02-13NoNoCurrent
0363-0189-46003630189461 BOTTLE, PLASTIC in 1 CARTON (0363-0189-46) / 96 TABLET in 1 BOTTLE, PLASTIC1990-04-100000-00-00NoNoCurrent