Childrens Triacting Nighttime

Product NDC
49580-0379
11-digit product format
495800379
Labeler code
49580
Product ID
49580-0379_f4d797cd-2bcd-41e6-b683-93d70e31da64
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
6.25; 2.5 mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Triacting Nighttime
Brand name suffix
Cold and Cough ReadyInCase
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE6.25 mg/5mL
DIPHENHYDRAMINE HYDROCHLORIDE2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1236048Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
61980e57-5b94-4ae2-8e08-848749e4abcdAvailable on FDA.report

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]7Current NDC, Legacy NDC, 2 package rows20231014_61980e57-5b94-4ae2-8e08-848749e4abcd.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 1 of 196 · 3,909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH464534ee-15f8-3af8-e063-6394a90a3f182026-08-24WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-20WarningsExact identifier
application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012

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