FDA.reportPublic FDA data

Daytime Cold and Flu

Product NDC
49035-466
11-digit product format
490350466
Labeler code
49035
Product ID
49035-466_84990a64-65ed-495f-af12-5a2866ef26b7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-30
Marketing end
2026-12-28
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
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 Cold and Flu
Brand name suffix
Non drowsy

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
db0f0164-3cbd-49b0-91ef-2e5218b09c3fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-466-12Daytime Cold and FluNon drowsy355 mL in 1 BOTTLE, PLASTICLIQUID3557

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
SORBITOLINACTIVE INGREDIENT506T60A25RDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WALMART STORES, INC.)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-466DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]6Current NDC, Legacy NDC, 1 package rows20240828_db0f0164-3cbd-49b0-91ef-2e5218b09c3f.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 13 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tukol Max Action Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAcf0987a3-2c1d-4f40-8551-df9a8e08cd3d2026-08-03WarningsExact identifier
application number: M012
Pressure, Pain and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.7d42e164-86e9-4baa-a389-3271cf99920e2026-08-03WarningsExact identifier
application number: M012
DG Health Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp Inced754d5c-74e1-4dee-a5c5-10ccec1b81db2026-08-03WarningsExact identifier
application number: M012
RIGHT REMEDIES Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINStrive Pharmaceuticals Inc.51c4dcfb-8725-d547-e063-6394a90ac04c2026-07-31WarningsExact identifier
application number: M012
Stona for ChildrenACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.18f3d694-9dff-407e-a264-916dbd201f9a2026-07-31WarningsExact identifier
application number: M012
StonarhiniCHLORPHENIRAMINE MALEATE, PHENYLEPHRINESato Pharmaceutical Co., Ltd.cc353280-0b4c-418c-93fe-8501259550092026-07-31WarningsExact identifier
application number: M012
cold and flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEMeijer Distribution Inc5519e918-71cb-4430-ae57-e03cd5ac60022026-07-31WarningsExact identifier
application number: M012
Good Neighbor Pharmacy allergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergen9819522f-f3db-4cb8-9680-423114ace2f62026-07-31WarningsExact identifier
application number: M012
Sinus Relief Daytime, NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation352b89b5-6995-4873-a103-e8f89074fdc92026-07-30WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HYDROCHLORIDEMeijer Distribution Incf1e83e43-011c-4470-bd55-fb2818a9fc842026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
TOPCARE NITE TIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC905d1c5c-65c8-47a3-ad7a-61a4b4b98f0d2026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012

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 SolutionPSNdb0f0164-3cbd-49b0-91ef-2e5218b09c3f7
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDdb0f0164-3cbd-49b0-91ef-2e5218b09c3f7
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYdb0f0164-3cbd-49b0-91ef-2e5218b09c3f7
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYdb0f0164-3cbd-49b0-91ef-2e5218b09c3f7
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYdb0f0164-3cbd-49b0-91ef-2e5218b09c3f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-466-1249035046612355 mL in 1 BOTTLE, PLASTIC (49035-466-12) 355 ml2015-06-302026-12-28NoNoCurrent