FDA.reportPublic FDA data

Nite-Time

Product NDC
76281-502
11-digit product format
762810502
Labeler code
76281
Product ID
76281-502_46e2d507-7545-48c8-e063-6294a90a6c67
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
LIQUID
Route
ORAL
Labeler
AptaPharma Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 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
2026-12-31
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
Brand name suffix
COLD/FLU Medicine Cherry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 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
1043400Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87c2b823-ed88-44f3-8f6a-df30430b40f3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-502-24Nite-TimeCOLD/FLU Medicine Cherry118 mL in 1 BOTTLELIQUID11811
76281-502-25Nite-TimeCOLD/FLU Medicine Cherry177 mL in 1 BOTTLELIQUID17711
76281-502-28Nite-TimeCOLD/FLU Medicine Cherry354 mL in 1 BOTTLELIQUID35411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-502NITE-TIME COLD/FLU MEDICINE CHERRY (ACETAMINOPHEN) LIQUID [APTAPHARMA INC.]9Current NDC, Legacy NDC, 3 package rows20231212_87c2b823-ed88-44f3-8f6a-df30430b40f3.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 163 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a2024-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)dbfb8971-a122-4a97-a665-e3f0d494876e2024-05-01WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLCc08b150c-d821-466c-8521-f77535d6af1e2024-04-30WarningsExact identifier
application number: M012
childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreen Company7848bb09-2af8-47f6-b32d-96635a750a552024-04-29WarningsExact identifier
application number: M012
NASAL and SINUS DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEJHK Inc dba American Safety & First Aid63e51305-2575-49c4-9fda-7b3e1b4b6ede2024-04-26WarningsExact identifier
application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore Throat NighttimeACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHaleon US Holdings LLC7decc168-e847-4bbe-910b-26081469406f2024-04-26WarningsExact identifier
application number: M012
Severe cold and flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIP & L Development, LLC7c92bdcf-db1f-4299-982f-6a3da9cba6e62024-04-25WarningsExact identifier
application number: M012
Severe cold and flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIP & L Development, LLC15727e06-7bfc-424e-9e68-cc9cd5695bfd2024-04-25WarningsExact identifier
application number: M012
Severe Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEP & L Development, LLC5872fed8-862b-44a2-a06e-51ebf86182712024-04-25WarningsExact identifier
application number: M012
CHERRY COUGH DROPS 50CTMENTHOL, UNSPECIFIED FORMJHK Inc dba American Safety & First Aid2f54b9c1-3a37-48fd-b964-6aa2631b8e622024-04-24WarningsExact identifier
application number: M012
Dye Free Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)f1a33c2f-2330-43f3-8026-de21808aec662024-04-22WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)fc7954a6-d061-4160-b1d1-a19eb9eabff42024-04-22WarningsExact identifier
application number: M012
Dibromm Cold and Allergy ChildrensBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)ea285d5a-9eb4-4f71-bb1b-4e24a89728192024-04-22WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)c573da1e-c7ca-46e6-ad42-4ded2547afc32024-04-22WarningsExact identifier
application number: M012
Cough Relief Cough SuppressantDEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)13ae4c67-a3fe-440c-91b8-c9412626c3cd2024-04-22WarningsExact identifier
application number: M012
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)47660794-22cc-4863-a183-e694d27e35432024-04-19WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)f9c08b18-a119-406b-bd96-73572b4445e22024-04-18WarningsExact identifier
application number: M012
Nighttime Cough ReliefDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)e1fa0f51-6a68-4f6f-8988-0949d1942c2f2024-04-18WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)025f6622-a6db-4a5c-aebd-5d54172fa4a12024-04-18WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)f9530d55-8226-4659-84f0-2c0b411572be2024-04-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN87c2b823-ed88-44f3-8f6a-df30430b40f311
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD87c2b823-ed88-44f3-8f6a-df30430b40f311
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY87c2b823-ed88-44f3-8f6a-df30430b40f311
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY87c2b823-ed88-44f3-8f6a-df30430b40f311
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY87c2b823-ed88-44f3-8f6a-df30430b40f311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76281-502-2476281050224118 mL in 1 BOTTLE (76281-502-24) 118 ml2018-01-01NoNoCurrent
76281-502-2576281050225177 mL in 1 BOTTLE (76281-502-25) 177 ml2018-01-010000-00-00NoNoCurrent
76281-502-2876281050228354 mL in 1 BOTTLE (76281-502-28) 354 ml2018-01-010000-00-00NoNoCurrent