day time

Product NDC
56062-656
11-digit product format
560620656
Labeler code
56062
Product ID
56062-656_b57c0992-a1bd-4577-9d7f-7364f864124d
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan HBr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Publix Super Markets Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-06-08
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage56062-65656062-656-38DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
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
f4fd597f-bca2-4ed4-b353-6c734f2f885cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-656-38day timenon drowsy296 mL in 1 BOTTLESOLUTION2969
56062-656-40day timenon drowsy355 mL in 1 BOTTLESOLUTION3559

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
56062-656-38ML - Milliliter56062-656e6c4567f-2e26-4a11-b556-665912b72adf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
SUCROSEINACTIVE INGREDIENTC151H8M554DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
WATERINACTIVE INGREDIENT059QF0KO0RDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-656DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]8Current NDC, Legacy NDC, 2 package rows20240927_f4fd597f-bca2-4ed4-b353-6c734f2f885c.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 27 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC3270f369-7a40-186d-e063-6394a90a85262026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe44d1ee-1e03-b74f-e053-6294a90a8bb42026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC31ac6883-ffcd-39de-e063-6294a90a52dd2026-05-19WarningsExact identifier
application number: M012
MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC325b41e1-f8d2-02ee-e063-6394a90aafff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC326f1fd3-73ab-e515-e063-6294a90ab2222026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC6c85df30-a601-4de6-9fd6-818265d799ff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7050b583-c09b-4457-9a9c-70c0923b62c02026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC27312ee4-d1f4-4a95-9c45-91fa5a01f5ba2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Daytime Pain, Headache, and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC37de53a7-5546-3804-e063-6294a90a0fb52026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC36b07e49-c72c-45e5-e063-6394a90a804a2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Clear and Cool Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2ee95e17-bd94-d717-e063-6294a90a21732026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Sinus Pressure Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2eeafd83-230c-af92-e063-6294a90a984e2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Congestion and Headache Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7017328-f8af-4601-9232-dc1104feaa0a2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC32375b12-75ed-d605-e063-6294a90ad0042026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC07da45b5-d05e-41b1-b233-f7034d556a8d2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and Pain Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCad4e0e4d-cc1f-4176-835f-3ba76564c6342026-05-19WarningsExact identifier
application number: M012
Childrens Mucinex Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC60daf6e2-ded8-44e6-bd8d-9d221384adde2026-05-19WarningsExact identifier
application number: M012
Mucinex Childrens Mini Melts Cold and FluACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC401fe0a0-ec97-5248-e063-6394a90af27f2026-05-19WarningsExact identifier
application number: M012
Childrens Cough and Congestion, Childrens Cold and Cough Day, NightDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINWALMART INC.312ae879-1124-40a4-b2ba-3f30708400212026-05-19WarningsExact identifier
application number: M012
GOOD SENSE DAYTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2597e84c-18b4-41a9-8e6a-ff0c4c1f06122026-05-18WarningsExact 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 SolutionPSNf4fd597f-bca2-4ed4-b353-6c734f2f885c9
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDf4fd597f-bca2-4ed4-b353-6c734f2f885c9
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYf4fd597f-bca2-4ed4-b353-6c734f2f885c9
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYf4fd597f-bca2-4ed4-b353-6c734f2f885c9
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYf4fd597f-bca2-4ed4-b353-6c734f2f885c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-656-3856062065638296 mL in 1 BOTTLE296 mlHistorical
56062-656-4056062065640355 mL in 1 BOTTLE (56062-656-40) 355 ml2014-03-270000-00-00NoNoCurrent