FDA.reportPublic FDA data

NIGHTTIME SEVERE COLD AND FLU

Product NDC
51316-477
11-digit product format
513160477
Labeler code
51316
Product ID
51316-477_7deea588-0213-4592-b56f-6db418bf8ff2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-14
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [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
NIGHTTIME SEVERE COLD AND FLU
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
V9BI9B5YI2Internal 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
1431245Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1115a55-35cd-4f20-8872-f42983a5ebcdAvailable on FDA.report

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 178 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and AllergyPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEAllegiant Health7af63769-fa56-4f1f-a2ad-5b4c108c8e4f2019-12-12WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESINAllegiant Health221d64a2-b8c7-435a-aae4-fb58fd38108f2019-03-26WarningsExact identifier
application number: M012
Sleep Tabs For Nighttime useDIPHENHYDRAMINE HCL TABLETSAllegiant Health566e40b1-e9d7-44e4-b971-eef2b7cf0a7d2018-12-26WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEAllegiant Health4305ad50-d2a5-4d3e-9d92-cbf26e856a162018-12-26WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCL 25 MGAllegiant Healthdbbc535f-515a-4d9b-b799-34e60f5230bb2018-12-21WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLAllegiant Healthc2823bad-540f-4662-8dcc-58e9f0d94efb2018-11-07WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum Strength Non-DrowsyPHENYLEPHRINE 10 MGAllegiant Health7aef00df-816a-4ea2-a2ad-beed66dd2fe42018-11-07WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa58bfb14-28f9-4425-a5a5-aaff4847c9792018-03-14WarningsExact identifier
application number: M012
Chlorpheniramine maleate 4mgCHLORPHENIRAMINE MALEATE 4MGAthlete's Needs, Inc.4d974959-25fc-4707-9b72-9afbf47b76f12017-11-14WarningsExact identifier
application number: M012
Cold MedicineACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLSelder, S.A. de C.V.d2762d9c-e7e7-42b2-a26a-14b2aa0307cb2017-01-25WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMarc Glassman, Inc.2051247f-ce64-4cf5-b449-9ca14c43ab862016-12-27WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-477-4051316047740355 mL in 1 BOTTLE (51316-477-40) 355 ml2026-07-14NoNoCurrent