FDA.reportPublic FDA data

DayTime

Product NDC
37808-656
11-digit product format
378080656
Labeler code
37808
Product ID
37808-656_1064a193-f147-4611-9579-858580903f2d
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-08-02
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 packagepackage37808-65637808-656-38DDiscontinued by firm2026-10-16

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
DayTime
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
e2994c0f-add8-4f75-a6d2-24cd2af271e4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-656-38DayTime296 mL in 1 BOTTLESOLUTION29610
37808-656-40DayTime355 mL in 1 BOTTLESOLUTION35510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
SUCROSEINACTIVE INGREDIENTC151H8M554DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-656DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]9Current NDC, Legacy NDC, 2 package rows20240927_e2994c0f-add8-4f75-a6d2-24cd2af271e4.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 111 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pentrexcilina Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e5c17-28f2-7186-e053-2995a90a51f62025-07-17WarningsExact identifier
application number: M012
Viro Flu PM ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe1553da8-3a89-e258-e053-2a95a90a47252025-07-17WarningsExact identifier
application number: M012
ACTICON PEDIATRICDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC3052cc67-e6c0-4d3f-9ec9-ffe58d9fae232025-07-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDemoulas Super Markets, Inc397f5acd-31c0-683e-e063-6394a90a7e542025-07-16WarningsExact identifier
application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC19ad2cca-c1cb-019c-e063-6294a90a56442025-07-16WarningsExact identifier
application number: M012
DG HEALTH COLD FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDolgencorp Inc8ea03891-2fbc-4413-8e6d-de903d426f8d2025-07-16WarningsExact identifier
application number: M012
up and up nighttime flu and severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationdf488727-b913-440b-9a0b-cce3ae143bf22025-07-15WarningsExact identifier
application number: M012
Topcare DayTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCbb9663e3-fd11-4e72-bf85-fee4841b795f2025-07-15WarningsExact identifier
application number: M012
DG HEALTH COLD FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Inc320e4f32-66aa-48be-9afd-fa2b2c217dc12025-07-14WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.f29da4ca-443d-7035-e053-2a95a90acab82025-07-14WarningsExact identifier
application number: M012
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS PHARMACYcdc9af7c-3766-4573-9d95-bf217907b9322025-07-11WarningsExact identifier
application number: M012
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILInternational Wholesale Inc398fee3d-7d93-9dbc-e063-6294a90abdcc2025-07-10WarningsExact identifier
application number: M012
HEADACHE RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINEKroger Companybbed29a1-3c52-3531-e053-2995a90a686c2025-07-10WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INCb765c82e-5021-4772-8647-c5ebc596bc0a2025-07-10WarningsExact identifier
application number: M012
Sinus Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyc378acaf-389a-4afb-a4f0-e367a907a4682025-07-10WarningsExact identifier
application number: M012
Nasal Decongestant Non-DrowsyPSEUDOEPHEDRINE HCLCVS Pharmacy3330b077-dab7-45c6-acbb-0f91f22712322025-07-09WarningsExact identifier
application number: M012
ACTIDOGESIC DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEACTIPHARMA, LLCff8e2565-bce3-4c06-a416-6e8f369f057f2025-07-09WarningsExact identifier
application number: M012
ACTINELDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLCdb0cb6ae-0a4d-4232-805a-f3f3a058261f2025-07-08WarningsExact identifier
application number: M012
HALLS Extra StrongMENTHOLMondelez Global LLC396f93a9-8d2c-2f27-e063-6294a90ab3442025-07-08WarningsExact identifier
application number: M012
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLCaea0335d-75e6-4a90-86a5-f197cf024a112025-07-08WarningsExact 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 SolutionPSNe2994c0f-add8-4f75-a6d2-24cd2af271e410
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDe2994c0f-add8-4f75-a6d2-24cd2af271e410
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYe2994c0f-add8-4f75-a6d2-24cd2af271e410
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYe2994c0f-add8-4f75-a6d2-24cd2af271e410
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYe2994c0f-add8-4f75-a6d2-24cd2af271e410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-656-3837808065638296 mL in 1 BOTTLE (37808-656-38) 296 ml2006-08-020000-00-00NoNoCurrent
37808-656-4037808065640355 mL in 1 BOTTLE (37808-656-40) 355 ml2012-07-200000-00-00NoNoCurrent