FDA.reportPublic FDA data

Good sense sleep aid

Product NDC
0113-0441
11-digit product format
001130441
Labeler code
0113
Product ID
0113-0441_8b72e4f7-ae3a-4f33-822b-c1ede77555f8
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA040167
Marketing category
ANDA
Marketing start
1997-04-14
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
Good sense sleep aid
Listing expiration
2026-12-31

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
0113-0441-01Good sense sleep aid96 in 1 BOTTLETABLET966
0113-0441-01Good sense sleep aid1 in 1 CARTONTABLET16
0113-0441-64Good sense sleep aid32 in 1 CARTONTABLET326
0113-0441-64Good sense sleep aid1 in 1 BLISTER PACKTABLET16
0113-0441-73Good sense sleep aid16 in 1 CARTONTABLET166
0113-0441-73Good sense sleep aid1 in 1 BLISTER PACKTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0441-64EA - Each0113-0441230e4cfb-4626-4042-8b63-3611ca54efff12012-07-24
0113-0441-73EA - Each0113-04413806255a-4778-4553-95bc-6123550320a512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2GOOD SENSE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [L. PERRIGO COMPANY]2
DOXYLAMINEACTIVE MOIETY95QB77JKPLGOOD SENSE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [L. PERRIGO COMPANY]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JGOOD SENSE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [L. PERRIGO COMPANY]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPGOOD SENSE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [L. PERRIGO COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [L. PERRIGO COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [L. PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0441GOOD SENSE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 6 package rows20250313_f0a0eb93-96e0-432b-9b82-f0e891483be0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSNf0a0eb93-96e0-432b-9b82-f0e891483be06
1101446doxylamine succinate 25 MG Oral TabletSCDf0a0eb93-96e0-432b-9b82-f0e891483be06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0441-01001130441011 BOTTLE in 1 CARTON (0113-0441-01) / 96 TABLET in 1 BOTTLE1 bottle2025-08-14NoNoCurrent
0113-0441-640011304416432 BLISTER PACK in 1 CARTON (0113-0441-64) / 1 TABLET in 1 BLISTER PACK32 blister pack1997-04-140000-00-00NoNoCurrent
0113-0441-730011304417316 BLISTER PACK in 1 CARTON (0113-0441-73) / 1 TABLET in 1 BLISTER PACK16 blister pack1997-08-030000-00-00NoNoCurrent