Sleep Aid

Product NDC
70677-1129
11-digit product format
706771129
Labeler code
70677
Product ID
70677-1129_628f0c66-70c5-4f46-ba2f-579df6af3691
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA040564
Marketing category
ANDA
Marketing start
2023-05-03
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
70677-1129-1Sleep Aid2 in 1 CARTONTABLET24
70677-1129-1Sleep Aid16 in 1 BLISTER PACKTABLET164

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1129-1EA - Each70677-1129228556a0-3d9a-4bb4-bab6-106dfc9535a912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1129SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 2 package rows20250512_eddec8bc-2bed-4bc5-a1c2-39424a699838.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSNeddec8bc-2bed-4bc5-a1c2-39424a6998384
1101446doxylamine succinate 25 MG Oral TabletSCDeddec8bc-2bed-4bc5-a1c2-39424a6998384

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1129-1706771129012 BLISTER PACK in 1 CARTON (70677-1129-1) / 16 TABLET in 1 BLISTER PACK2 blister pack2023-05-03NoNoHistorical