FDA.reportPublic FDA data

Sleep Tabs

Product NDC
0904-4274
11-digit product format
009044274
Labeler code
0904
Product ID
0904-4274_2c24af3d-ceb2-4dc6-b133-e2f8e8886ac0
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Tabs
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-4274-51Sleep Tabs50 in 1 BOTTLE, PLASTICTABLET5020
0904-4274-51Sleep Tabs1 in 1 CARTONTABLET120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-4274-51EA - Each0904-4274dccff74a-1b09-4937-a791-71ca5c77879312013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]7
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-4274SLEEP TABS (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]19Current NDC, Legacy NDC, 2 package rows20250311_ff8b7346-5be5-4e76-9ee2-d52fab66f6c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNff8b7346-5be5-4e76-9ee2-d52fab66f6c520
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDff8b7346-5be5-4e76-9ee2-d52fab66f6c520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-4274-51009044274511 BOTTLE, PLASTIC in 1 CARTON (0904-4274-51) / 50 TABLET in 1 BOTTLE, PLASTIC1990-04-100000-00-00NoNoCurrent