FDA.reportPublic FDA data

DayTime

Product NDC
37808-656
11-digit product format
378080656
Labeler code
37808
Product ID
37808-656_1064a193-f147-4611-9579-858580903f2d
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-08-02
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DayTime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1113705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-656-38DayTime296 mL in 1 BOTTLESOLUTION29610
37808-656-40DayTime355 mL in 1 BOTTLESOLUTION35510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
SUCROSEINACTIVE INGREDIENTC151H8M554DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-656DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]9Current NDC, Legacy NDC, 2 package rows20240927_e2994c0f-add8-4f75-a6d2-24cd2af271e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNe2994c0f-add8-4f75-a6d2-24cd2af271e410
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDe2994c0f-add8-4f75-a6d2-24cd2af271e410
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYe2994c0f-add8-4f75-a6d2-24cd2af271e410
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYe2994c0f-add8-4f75-a6d2-24cd2af271e410
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYe2994c0f-add8-4f75-a6d2-24cd2af271e410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-656-3837808065638296 mL in 1 BOTTLE (37808-656-38) 296 ml2006-08-020000-00-00NoNoCurrent
37808-656-4037808065640355 mL in 1 BOTTLE (37808-656-40) 355 ml2012-07-200000-00-00NoNoCurrent