FDA.reportPublic FDA data

DayTime Cold and Flu

Product NDC
53345-004
11-digit product format
533450004
Labeler code
53345
Product ID
53345-004_2752d028-7e6a-bcdc-e063-6394a90a26eb
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-15
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/1; mg/1; mg/1
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
2026-12-31
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 Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

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
1086997Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b55d1df-275b-40d8-bde3-fc43313b7eb3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53345-004-01DayTime Cold and Flu1 in 1 BOXCAPSULE, LIQUID FILLED14
53345-004-01DayTime Cold and Flu4000 in 1 BAGCAPSULE, LIQUID FILLED40004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
GELATININACTIVE INGREDIENT2G86QN327LDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
SORBITOLINACTIVE INGREDIENT506T60A25RDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-004DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]4Current NDC, Legacy NDC, 2 package rows20241123_5b55d1df-275b-40d8-bde3-fc43313b7eb3.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 25 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC9aca1a68-893c-4770-8a48-d5d6780582532026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCd26b5143-aa07-4114-a6ba-4f503aadd46f2026-05-27WarningsExact identifier
application number: M012
Goodmeds Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.37533188-8c91-428b-a796-c5afd9e4959f2026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC8252cdec-b668-4450-b045-e093479ab5422026-05-27WarningsExact identifier
application number: M012
Delsym Nighttime CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC27f9d2db-38ce-41d2-8f1a-0eb1716002742026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Sore ThroatACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCb37b786e-0cce-419d-94ed-3b64a1eb12012026-05-27WarningsExact identifier
application number: M012
Delsym CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCa43d59f9-3a6c-4a7c-b98d-b86d6035f7162026-05-27WarningsExact identifier
application number: M012
Cold and Flu Relief Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation5700ef26-ffa6-480a-bf36-bd5111799e9b2026-05-27WarningsExact identifier
application number: M012
Air PowerGUAIFENESINSchwabe North America, Inc5cdefc7a-6242-4681-88a3-04422a1d48d32026-05-27WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALMART INC.adb658c8-db8d-4db6-80c8-e0f2de88a2de2026-05-27WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacyc71427d4-707f-411f-8bd4-133517a9992b2026-05-26WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLCVS PHARMACY, INC643e929d-9e62-4260-91ee-e88a184dd7cd2026-05-26WarningsExact identifier
application number: M012
TopCare Day Time Nite Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCc00ff684-acaf-4fbe-bc74-7e48751b927d2026-05-26WarningsExact identifier
application number: M012
Goodmeds Non-Drowsy Nasal Decongestant PEPHENYLEPHRINECabinet Health P.B.C.4e75da23-35f2-431c-92cb-c2c4cb3f09f12026-05-26WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS Pharmacy13492631-d5de-4562-a201-664f7d3591de2026-05-26WarningsExact identifier
application number: M012
Sinufrin DecongestantNASAL CONGESTION RELIEFNeilMed Pharmaceuticals Inc52a2e5f9-e0a2-02f7-e063-6294a90a3ae92026-05-25WarningsExact identifier
application number: M012
Cough Suppressant AdultDEXTROMETHORPHAN HYDROBROMIDERugby Laboratories47b713bd-4c1e-f44a-e063-6294a90a63d32026-05-25WarningsExact identifier
application number: M012
ClorReliefCHLORPHENIRAMINE MALEATEFERRER MEDICAL INNOVATIONS LLCdb729011-f72f-5911-e053-2a95a90a68bf2026-05-22WarningsExact identifier
application number: M012
Childrens Dye Free Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporation74ff4f0d-7952-4b74-b1b2-5a2beab91f7c2026-05-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN5b55d1df-275b-40d8-bde3-fc43313b7eb34
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD5b55d1df-275b-40d8-bde3-fc43313b7eb34
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY5b55d1df-275b-40d8-bde3-fc43313b7eb34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53345-004-01533450004011 BAG in 1 BOX (53345-004-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2013-06-150000-00-00NoNoCurrent