Sleep Aid

Product NDC
55301-986
11-digit product format
553010986
Labeler code
55301
Product ID
55301-986_f814504b-d6f4-4ced-b700-806ed966f68b
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine Succinate
Dosage form
TABLET
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
ANDA040564
Marketing category
ANDA
Marketing start
2019-04-01
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
55301-986-27Sleep Aid16 in 1 BLISTER PACKTABLET1611
55301-986-27Sleep Aid2 in 1 CARTONTABLET211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-986SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]9Current NDC, Legacy NDC, 2 package rows20250525_009df4c9-a524-4b8f-be7a-52c521e68ff1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN009df4c9-a524-4b8f-be7a-52c521e68ff111
1101446doxylamine succinate 25 MG Oral TabletSCD009df4c9-a524-4b8f-be7a-52c521e68ff111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-986-27553010986272 BLISTER PACK in 1 CARTON (55301-986-27) / 16 TABLET in 1 BLISTER PACK2 blister pack2019-04-010000-00-00NoNoCurrent