sleep aid

Product NDC
11822-0441
11-digit product format
118220441
Labeler code
11822
Product ID
11822-0441_bbf03df3-4f24-48d1-a2a3-74b83a0cb3cd
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA040167
Marketing category
ANDA
Marketing start
2023-03-13
Marketing end
2027-07-31
Substance
DOXYLAMINE SUCCINATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV9BI9B5YI2
Rxcui1101446

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0441-0sleep aid48 in 1 CARTONTABLET484
11822-0441-0sleep aid1 in 1 BLISTER PACKTABLET14
11822-0441-1sleep aid96 in 1 BOTTLETABLET964
11822-0441-1sleep aid1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0441SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [RITE AID CORPORATION]3Current NDC, 4 package rows20250305_4b5fdb06-f205-4424-b4cb-dddef921485b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN4b5fdb06-f205-4424-b4cb-dddef921485b4
1101446doxylamine succinate 25 MG Oral TabletSCD4b5fdb06-f205-4424-b4cb-dddef921485b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0441-01182204410048 BLISTER PACK in 1 CARTON (11822-0441-0) / 1 TABLET in 1 BLISTER PACK48 blister pack2023-03-132027-07-31NoNoHistorical
11822-0441-1118220441011 BOTTLE in 1 CARTON (11822-0441-1) / 96 TABLET in 1 BOTTLE1 bottle2023-03-132026-09-30NoNoHistorical