NDC 49580-0379-04 - Childrens Triacting Nighttime Cold and Cough ReadyInCase

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49580-0379
Requested NDC
49580-0379-04
Package NDCs from labels
49580-0379-4, 49580-0379-04
Manufacturer
P & L Development, LLC
Effective date
2023-10-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diphenhydramine HCl, Phenylephrine HCl - P & L Development, LLCP & L Development, LLC2023-10-13HUMAN OTC DRUG LABEL

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 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

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

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 258 · 5,152 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLC1767c4b7-36a0-4e64-9091-2af22161402f2026-07-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLCf43e4abd-0083-4fe5-9c27-0ba9245e51382026-07-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
unii: TC2D6JAD40
ADVIL PMDIPHENHYDRAMINE HCL, IBUPROFENHaleon US Holdings LLC405afdb4-c157-1d88-f232-848063ba47142026-07-29WarningsExact identifier
unii: TC2D6JAD40
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
unii: TC2D6JAD40
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
unii: TC2D6JAD40