FDA.reportPublic FDA data

Daytime

Product NDC
57243-506
11-digit product format
572430506
Labeler code
57243
Product ID
57243-506_49c1c962-2dba-479b-b98a-a70e9d7dd68b
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Salado Sales, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-05
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Daytime
Brand name suffix
Non-Drowsy COLD/FLU
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1113705Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e181b371-78c7-4163-865d-acc064be33caAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57243-506-25DaytimeNon-Drowsy COLD/FLU177 mL in 1 BOTTLELIQUID1775

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57243-506DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]5Current NDC, Legacy NDC, 1 package rows20231230_e181b371-78c7-4163-865d-acc064be33ca.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 22 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC01f41fae-4abb-4b96-ab09-a7d3dfc286cd2026-01-26WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Incec4dbb71-b507-42a3-9b68-14d4b6621ec12026-01-23WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINNCS HealthCare of KY, LLC dba Vangard Labs9105eff0-1c22-4298-8ee5-9fb7a1de12f12026-01-23WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENPreferred Pharmaceuticals Inc.c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2026-01-22WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC17cfa99d-abb2-4d77-9e0e-e77109fbb61a2026-01-21WarningsExact identifier
application number: M013
Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mgACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MGFarmacias De Similares TX LLC48ea0a2c-511b-4805-e063-6394a90a12252026-01-21WarningsExact identifier
application number: M013
childrens mapapACETAMINOPHENMajor Pharmaceuticalsa1b0ccf0-cf24-4b34-b42a-aa1cc1e57f602026-01-20WarningsExact identifier
application number: M013
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENWALGREENS CO.9b756e4e-6c56-43aa-a5bc-5b649440e7592026-01-20WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVER PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALGREENS CO.5a58d620-a0ec-48d7-92dd-3f3f78ec10ea2026-01-20WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWal-Mart Stores Incd4e438c6-80dd-4531-91e6-bc4ca7a8570f2026-01-20WarningsExact identifier
application number: M013
Unishield Extra Strength Non-AspirinACETAMINOPHENUnishieldba0ec1eb-db85-6a7f-e053-2995a90aafe52026-01-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENHyVee Inc24acd62f-72b1-418a-b733-7e4888f3c0a32026-01-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCardinal Health 110, LLC. DBA Leaderdd8b13a5-07df-4cec-92c3-1a662b1e1a562026-01-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS7d8f8389-730d-494e-a0af-5a91a3c99e172026-01-16WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN AND CAFFEINEWALGREENS54aff6a0-2778-472f-90ba-375d6bce6ee82026-01-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS097fbab7-3886-4e75-b037-f03adcf3859f2026-01-16WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS CO.bdb09e15-8e17-4987-99d0-bab8856a21092026-01-16WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst4870ff00-f727-814d-e063-6394a90a6c8e2026-01-15WarningsExact identifier
application number: M013
AspirinASPIRINHyVee Inc957b13a4-4086-459f-8fa0-9708b317fabe2026-01-15WarningsExact identifier
application number: M013
Unisom PM Pain Nighttime Sleep Aid and Pain RelieverACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb2026-01-14WarningsExact identifier
application number: M013

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 SolutionPSNe181b371-78c7-4163-865d-acc064be33ca5
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDe181b371-78c7-4163-865d-acc064be33ca5
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYe181b371-78c7-4163-865d-acc064be33ca5
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYe181b371-78c7-4163-865d-acc064be33ca5
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYe181b371-78c7-4163-865d-acc064be33ca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57243-506-2557243050625177 mL in 1 BOTTLE (57243-506-25) 177 ml2012-09-050000-00-00NoNoCurrent