FDA.reportPublic FDA data

Childrens Triacting Nighttime

Product NDC
49580-0379
Requested package NDC
49580-0379-4
11-digit product format
495800379
Labeler code
49580
Product ID
49580-0379_9a415bb9-dcfb-4c83-b681-4454f0a08a92
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-30
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
3 mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage49580-037949580-0379-4DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0379-4Childrens Triacting NighttimeCold and Cough ReadyInCase1 in 1 BOXLIQUID17
49580-0379-4Childrens Triacting NighttimeCold and Cough ReadyInCase118 mL in 1 BOTTLE, PLASTICLIQUID1187

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
MALTITOLINACTIVE INGREDIENTD65DG142WKCHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [AARON INDUSTRIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0379CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [P & L DEVELOPMENT, LLC]7Legacy NDC, 2 package rows20231014_61980e57-5b94-4ae2-8e08-848749e4abcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1236048diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN61980e57-5b94-4ae2-8e08-848749e4abcd7
1236048diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD61980e57-5b94-4ae2-8e08-848749e4abcd7
1236048diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY61980e57-5b94-4ae2-8e08-848749e4abcd7
1236048diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY61980e57-5b94-4ae2-8e08-848749e4abcd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49580-0379-4495800379041 BOTTLE, PLASTIC in 1 BOX (49580-0379-4) > 118 mL in 1 BOTTLE, PLASTIC2014-11-300000-00-00NoNoCurrent