FDA.reportPublic FDA data

Day Time Cold and Flu Relief

Product NDC
21130-866
11-digit product format
211300866
Labeler code
21130
Product ID
21130-866_5627f1a1-b04f-4b93-84ff-5494850e1f1d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Safeway, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-31
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
Day Time Cold and Flu Relief
Brand name suffix
non drowsy
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
cc450f89-a156-48e0-82ae-19782f13c2caAvailable on FDA.report

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
21130-866-08Day Time Cold and Flu Reliefnon drowsy237 mL in 1 BOTTLE, PLASTICLIQUID2377
21130-866-12Day Time Cold and Flu Reliefnon drowsy355 mL in 1 BOTTLE, PLASTICLIQUID3557

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-866DAY TIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]7Current NDC, Legacy NDC, 2 package rows20240514_cc450f89-a156-48e0-82ae-19782f13c2ca.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 170 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYaf5053d8-ba02-4cdf-877f-8c1e368dafe02024-01-10WarningsExact identifier
application number: M012
HISTEXTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLCcc466d33-cf3e-4f1c-a794-6d3d79903adf2024-01-08WarningsExact identifier
application number: M012
HISTEX-DMDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC836d062c-29f0-4fd7-b65c-771a3bbd52c42024-01-08WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLA-S Medication Solutionse1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd2024-01-08WarningsExact identifier
application number: M012
AXIM DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINVIVUNT PHARMA LLC0e7424ea-461f-5ead-e063-6294a90a41b62024-01-05WarningsExact identifier
application number: M012
AXIM Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC0e740063-80d5-c48b-e063-6394a90a3b302024-01-05WarningsExact identifier
application number: M012
AXIM DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC0e742e10-daea-6443-e063-6294a90ab5af2024-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3c3e0dc8-cddd-4f46-9b68-19bac00c07cc2024-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLA-S Medication Solutionsfa12a5a8-bf2d-4991-9d54-9c519e8e04cd2024-01-04WarningsExact identifier
application number: M012
NASAL DECONGESTANT PE 10mgPHENYLPHRINE HCLYYBA CORP05824fc4-ef3f-4ebb-b601-252f76ad60ef2024-01-03WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP5943d975-77e4-4cbd-b2d9-d699052fe82a2024-01-01WarningsExact identifier
application number: M012
Coricidin HBP Cold and FluACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEProficient Rx LPac79a7dd-c26e-47d2-8fb9-768d2d09e5072024-01-01WarningsExact identifier
application number: M012
Oxymethazoline HCLOXYMETHAZOLINE HCLProficient Rx LP96883e5f-18b5-4c1c-b984-756cb86be6ff2024-01-01WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP6e91b9c3-57e8-488b-ac70-d863cdf9d6e82024-01-01WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEProficient Rx LP9e067482-8735-4476-a82e-438dd24d42892024-01-01WarningsExact identifier
application number: M012
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.94e02be4-b8a6-422a-8f66-e6a69e924b2c2023-12-30WarningsExact identifier
application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DMDEXTROMETHORPHAN HYDROBROMIDEAptaPharma Inc.8a4c55d0-c472-4e89-9fdb-17ecf0af48562023-12-30WarningsExact identifier
application number: M012
XL-3 XtremeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAptaPharma Inc.dff79e0b-edf0-4dd3-a722-fd9beecd62932023-12-30WarningsExact identifier
application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSalado Sales, Inc.e25727d0-7dd7-4ef5-b064-7938679f075f2023-12-29WarningsExact identifier
application number: M012
Maximum Strength DM MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINH E Bbb56d09d-ecb0-469e-a16f-f9f1a48942a82023-12-29WarningsExact 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 SolutionPSNcc450f89-a156-48e0-82ae-19782f13c2ca7
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDcc450f89-a156-48e0-82ae-19782f13c2ca7
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYcc450f89-a156-48e0-82ae-19782f13c2ca7
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYcc450f89-a156-48e0-82ae-19782f13c2ca7
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYcc450f89-a156-48e0-82ae-19782f13c2ca7
2637726{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } PackGPCKf762600a-f4b1-4869-a04b-8431c3d8a3e36
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) PackPSNf762600a-f4b1-4869-a04b-8431c3d8a3e36
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNf762600a-f4b1-4869-a04b-8431c3d8a3e36
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNf762600a-f4b1-4869-a04b-8431c3d8a3e36
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDf762600a-f4b1-4869-a04b-8431c3d8a3e36
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDf762600a-f4b1-4869-a04b-8431c3d8a3e36
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) PackSYf762600a-f4b1-4869-a04b-8431c3d8a3e36
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYf762600a-f4b1-4869-a04b-8431c3d8a3e36
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYf762600a-f4b1-4869-a04b-8431c3d8a3e36
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYf762600a-f4b1-4869-a04b-8431c3d8a3e36
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYf762600a-f4b1-4869-a04b-8431c3d8a3e36
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYf762600a-f4b1-4869-a04b-8431c3d8a3e36
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYf762600a-f4b1-4869-a04b-8431c3d8a3e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-866-0821130086608237 mL in 1 BOTTLE, PLASTIC (21130-866-08) 237 ml2015-08-310000-00-00NoNoCurrent
21130-866-1221130086612355 mL in 1 BOTTLE, PLASTIC (21130-866-12) 355 ml2015-08-310000-00-00NoNoCurrent