FDA.reportPublic FDA data

Daytime Cold and Flu

Product NDC
63868-020
11-digit product format
638680020
Labeler code
63868
Product ID
63868-020_da167ca4-2477-45d1-974d-f784025ca7d3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-30
Marketing end
2027-01-30
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
df866cf6-0526-4e61-ac9b-245b57dd5df6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-020-08Daytime Cold and FluNon Drowsy237 mL in 1 BOTTLE, PLASTICLIQUID2377
63868-020-12Daytime Cold and FluNon Drowsy355 mL in 1 BOTTLE, PLASTICLIQUID3557

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-020-08ML - Milliliter63868-020e7745249-c4b3-4c2f-83bd-3ec0f2ac756012018-03-08
63868-020-12ML - Milliliter63868-02013afa728-907f-40f1-8d08-ee8a4a0af19512018-03-08

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-020DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]6Current NDC, Legacy NDC, 2 package rows20240423_df866cf6-0526-4e61-ac9b-245b57dd5df6.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 31 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCINEX Rapid Clear Day Night and Clear and Cool NasalACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC37dcb0ed-df56-1bec-e063-6394a90a695e2026-05-13WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC373e0d75-8def-4b98-e063-6394a90a5e472026-05-13WarningsExact identifier
application number: M012
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASALOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC5a397466-8721-4060-a178-5ebfd7069cc92026-05-13WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC350764de-7801-b24e-e063-6394a90ab3c32026-05-13WarningsExact identifier
application number: M012
Cepacol Extra Strength Sore Throat and CoughBENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc0cc32db-90f0-4106-8538-89821083ece12026-05-13WarningsExact identifier
application number: M012
Mucinex Cold and FluACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLCe8bc4131-f7b0-926a-e053-2995a90a40ac2026-05-13WarningsExact identifier
application number: M012
Mucinex Cold, Flu, and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC37ded76a-ee8d-f22c-e063-6394a90a00c22026-05-13WarningsExact identifier
application number: M012
Mucinex Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCfdb5c937-c148-eb46-e053-6394a90a8bed2026-05-13WarningsExact identifier
application number: M012
Mucinex Cough Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINReckitt Benckiser LLCe9c32d81-cd9b-4ff2-e053-2995a90aa4992026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC316b5569-b66f-f30c-e063-6394a90ae1472026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCd9467ca2-df75-4fa1-92b3-d2101eb54a772026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC12420092-3ef6-464b-9106-2d56cd6ef2002026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC09fdf96f-345f-43f2-9f0f-8303ac70849e2026-05-13WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC2ce31244-9c6c-b7dd-e063-6394a90a31a82026-05-13WarningsExact identifier
application number: M012
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc2ac53cc7-000f-41fd-b799-4e6d6886fe622026-05-13WarningsExact identifier
application number: M012
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc2201d5c0-bd51-47a7-9775-916b185736232026-05-13WarningsExact identifier
application number: M012
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLCf868e4a0-e9fb-4e6a-9984-29a2182462412026-05-13WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Inc582fa36b-6d0c-4ff3-80ab-6e0da4b209e42026-05-13WarningsExact identifier
application number: M012
SudoGestPSEUDOEPHEDRINE HYDROCHLORIDEMajor Pharmaceuticals78faa497-6743-b85b-e053-2a91aa0ae8222026-05-12WarningsExact identifier
application number: M012
Allergy Relief mini SoftgelsDIPHENHYDRAMINE HCI 25 MGCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdf1c620b-ff59-4126-99a5-1d6750888f2b2026-05-12WarningsExact 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 SolutionPSNdf866cf6-0526-4e61-ac9b-245b57dd5df67
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDdf866cf6-0526-4e61-ac9b-245b57dd5df67
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYdf866cf6-0526-4e61-ac9b-245b57dd5df67
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYdf866cf6-0526-4e61-ac9b-245b57dd5df67
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYdf866cf6-0526-4e61-ac9b-245b57dd5df67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-020-0863868002008237 mL in 1 BOTTLE, PLASTIC (63868-020-08) 237 ml2015-06-302027-01-30NoNoCurrent
63868-020-1263868002012355 mL in 1 BOTTLE, PLASTIC (63868-020-12) 355 ml2015-06-302027-01-30NoNoCurrent