NITE TIME INTENSE FLU

Product NDC
79481-0203
11-digit product format
794810203
Labeler code
79481
Product ID
79481-0203_95e5f33e-c862-4399-901b-2f104330a34c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Meijer, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
1000; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
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]
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
NITE TIME INTENSE FLU
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN1000 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

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
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1042684Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
161c34b4-3cd2-40b4-b13e-ad980ad4249cAvailable 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 153 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care nasalPHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC858648f6-f454-4008-9ea8-ad060c2178332024-10-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDENavajo Manufacturing Company Inc.f6068011-ad56-59b4-e053-2995a90ac0162024-10-03WarningsExact identifier
application number: M012
Benadryl UltratabsDIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.76433e3c-142c-4704-8b2b-d602f008c3772024-10-02WarningsExact identifier
application number: M012
AfrinOXYMETAZOLINE HYDROCHLORIDENavajo Manufacturing Company Inc.65bf1556-f234-9439-e053-2a91aa0a31942024-10-02WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLProficient Rx LP4eab4344-d95e-4b19-a21e-9c8ad033863a2024-10-01WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLProficient Rx LPa910320b-0585-40bd-928c-0406346281d02024-10-01WarningsExact identifier
application number: M012
CareOne Nasal and Sinus DecongestantPSEUDOEPHEDRINE HCLAmerican Sales Company81b31070-9b03-4ce4-8aac-a334544842ae2024-10-01WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINProficient Rx LP20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d2024-10-01WarningsExact identifier
application number: M012
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.1bec5167-5fc5-2405-e063-6294a90a53582024-09-30WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINA-S Medication Solutions19b3db33-86d1-48f3-9525-c7c87a4b68992024-09-29WarningsExact identifier
application number: M012
nasal decongestant maximum strength non drowsyPSEUDOEPHEDRINE HCLMeijer Distribution Inc8a68ca99-fd76-409a-9769-88830e8720a82024-09-28WarningsExact identifier
application number: M012
good neighbor pharmacy tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergen58687394-b6d2-4d51-bde0-8f2cfa3fe9092024-09-27WarningsExact identifier
application number: M012
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEAmerisource Bergenfaee3aae-e819-4084-a127-3449be353b132024-09-27WarningsExact identifier
application number: M012
Tesalon ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCLOPMX LLC2309620a-ccbc-41e9-e063-6394a90a95202024-09-26WarningsExact identifier
application number: M012
adult cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.b11c4cee-bbb5-4585-9d38-6787553e13a02024-09-26WarningsExact identifier
application number: M012
COLD AND FLU NIGHTTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9c34e-a0ca-cdf9-e053-2a95a90a93d32024-09-25WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC8f3317f6-4ae8-474b-93c3-25e256519cb82024-09-25WarningsExact identifier
application number: M012
berkley and jensen tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINBJWCb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2024-09-24WarningsExact identifier
application number: M012
Tussin DM Cough and Chest Non DrowsyDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC13eb459c-3075-4038-8062-9ee7175b2ab92024-09-24WarningsExact identifier
application number: M012
equaline nasal decongestant non drowsy maximum strengthPSEUDOEPHEDRINE HCLUnited Natural Foods, Inc. dba UNFI8897580a-709a-4643-8264-ad003d90cbff2024-09-22WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0203-079481020300355 mL in 1 BOTTLE (79481-0203-0) 355 ml2026-07-01NoNoCurrent