FDA.reportPublic FDA data

Sanatos

Product NDC
14505-399
11-digit product format
145050399
Labeler code
14505
Product ID
14505-399_af1e5459-2fd9-4c0f-af63-bea42e73c14d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
Pharmalab Enterprises Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-02-04
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
500 mg/15mL; mg/15mL; mg/15mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14505-399-062019-10-21C16284748780-1956f9ecf-defc-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14505-399-06SanatosNight177 mL in 1 BOTTLE, PLASTICLIQUID1772

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2SANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
DOXYLAMINEACTIVE MOIETY95QB77JKPLSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2
WATERINACTIVE INGREDIENT059QF0KO0RSANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14505-399SANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]2Legacy NDC, 1 package rows20100909_8816ec3c-2a26-4bd5-9ba6-8f7fce999470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1042684acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral SolutionPSN8816ec3c-2a26-4bd5-9ba6-8f7fce9994702
1042684acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD8816ec3c-2a26-4bd5-9ba6-8f7fce9994702
1042684acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY8816ec3c-2a26-4bd5-9ba6-8f7fce9994702
1042684acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY8816ec3c-2a26-4bd5-9ba6-8f7fce9994702
1042684APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY8816ec3c-2a26-4bd5-9ba6-8f7fce9994702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
14505-399-0614505039906177 mL in 1 BOTTLE, PLASTIC177 mlHistorical