FDA.reportPublic FDA data

Sleep Aid

Product NDC
0363-0367
11-digit product format
003630367
Labeler code
0363
Product ID
0363-0367_959cf59d-54ea-4e34-90ea-27261017b2a3
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-06-10
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 Aid
Brand name suffix
Nighttime
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
0363-0367-08Sleep AidNighttime12 in 1 BLISTER PACKTABLET, FILM COATED1219
0363-0367-08Sleep AidNighttime2 in 1 CARTONTABLET, FILM COATED219
0363-0367-12Sleep AidNighttime100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10019
0363-0367-12Sleep AidNighttime1 in 1 CARTONTABLET, FILM COATED119
0363-0367-13Sleep AidNighttime250 in 1 BOTTLE, PLASTICTABLET, FILM COATED25019
0363-0367-13Sleep AidNighttime1 in 1 CARTONTABLET, FILM COATED119
0363-0367-91Sleep AidNighttime1 in 1 CARTONTABLET, FILM COATED119
0363-0367-91Sleep AidNighttime125 in 1 BOTTLETABLET, FILM COATED12519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0367-08EA - Each0363-0367a34df953-b3d2-4a1f-bc09-73355ba1b57812015-10-02
0363-0367-12EA - Each0363-0367cabdb671-984e-48fc-bdd8-7ac4e6eb091b12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5
TALCINACTIVE INGREDIENT7SEV7J4R1USLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0367SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]18Current NDC, Legacy NDC, 8 package rows20250512_ec3618dd-8713-4f3c-b639-fc240021c7be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNec3618dd-8713-4f3c-b639-fc240021c7be19
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDec3618dd-8713-4f3c-b639-fc240021c7be19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0367-08003630367082 BLISTER PACK in 1 CARTON (0363-0367-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2000-06-100000-00-00NoNoCurrent
0363-0367-12003630367121 BOTTLE, PLASTIC in 1 CARTON (0363-0367-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2000-06-100000-00-00NoNoCurrent
0363-0367-13003630367131 BOTTLE, PLASTIC in 1 CARTON (0363-0367-13) / 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2000-06-100000-00-00NoNoCurrent
0363-0367-91003630367911 BOTTLE in 1 CARTON (0363-0367-91) > 125 TABLET, FILM COATED in 1 BOTTLE1 bottle2000-06-102021-10-02NoNoCurrent