Sleep Aid

Product NDC
49035-968
11-digit product format
490350968
Labeler code
49035
Product ID
49035-968_923a648d-7b97-454f-99f0-ba3c4af71b6f
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA040564
Marketing category
ANDA
Marketing start
2019-07-15
Substance
DOXYLAMINE SUCCINATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
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
Listing expiration
2027-12-31

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
49035-968-27Sleep Aid32 in 1 BOTTLE, PLASTICTABLET3212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-968-27EA - Each49035-968c3e905b2-f525-4f0b-b6ad-f8e629fdf39b12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-968SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WAL-MART STORES INC]11Current NDC, Legacy NDC, 1 package rows20250512_71e0cef1-6195-4b67-9c1f-b4e5fbeae53c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN71e0cef1-6195-4b67-9c1f-b4e5fbeae53c12
1101446doxylamine succinate 25 MG Oral TabletSCD71e0cef1-6195-4b67-9c1f-b4e5fbeae53c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-968-274903509682732 TABLET in 1 BOTTLE, PLASTIC (49035-968-27) 32 tablet2019-07-150000-00-00NoNoCurrent