FDA.reportPublic FDA data

NIGHTTIME SLEEP AID

Product NDC
59779-441
11-digit product format
597790441
Labeler code
59779
Product ID
59779-441_16ca467b-a34f-4839-a0f2-feb1a2b446ce
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA040167
Marketing category
ANDA
Marketing start
1997-07-23
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
NIGHTTIME 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
59779-441-01NIGHTTIME SLEEP AID96 in 1 BOTTLETABLET9612
59779-441-01NIGHTTIME SLEEP AID1 in 1 CARTONTABLET112
59779-441-64NIGHTTIME SLEEP AID16 in 1 BLISTER PACKTABLET1612
59779-441-64NIGHTTIME SLEEP AID2 in 1 CARTONTABLET212
59779-441-67NIGHTTIME SLEEP AID1 in 1 BLISTER PACKTABLET112
59779-441-67NIGHTTIME SLEEP AID48 in 1 CARTONTABLET4812

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-441-01EA - Each59779-4410a53acda-d55d-44ff-9337-a4666dd4347212018-08-13
59779-441-64EA - Each59779-4418735e260-fdbf-45b0-9cc4-999855674c2612022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [CVS PHARMACY]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLNIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-441NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [CVS PHARMACY]11Current NDC, Legacy NDC, 6 package rows20250305_05050b61-2417-48f0-9478-c39d6a341026.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN05050b61-2417-48f0-9478-c39d6a34102612
1101446doxylamine succinate 25 MG Oral TabletSCD05050b61-2417-48f0-9478-c39d6a34102612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-441-01597790441011 BOTTLE in 1 CARTON (59779-441-01) / 96 TABLET in 1 BOTTLE1 bottle2018-05-090000-00-00NoNoCurrent
59779-441-645977904416416 in 1 BLISTER PACKHistorical
59779-441-675977904416748 BLISTER PACK in 1 CARTON (59779-441-67) > 1 TABLET in 1 BLISTER PACK48 blister pack2018-04-182022-11-30NoNoCurrent