FDA.reportPublic FDA data

Childrens Multi-Symptom Cold and Fever Relief

Product NDC
67091-221
11-digit product format
670910221
Labeler code
67091
Product ID
67091-221_d64c27e5-b06f-461c-ae27-b483066eccf9
Type
HUMAN OTC DRUG
Nonproprietary name
Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
WinCo Foods, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-12-12
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Active strength
325 mg/10mL; mg/10mL; mg/10mL; mg/10mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67091-221-182022-01-28C16284748780-1d6a99b39-9f64-a426-e053-dadaa90af4c2Childrens Multi-Symptom Cold & Fever Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-221-18Childrens Multi-Symptom Cold and Fever Relief1 in 1 CARTONLIQUID12
67091-221-18Childrens Multi-Symptom Cold and Fever Relief118 mL in 1 BOTTLELIQUID1182

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
GUAIFENESINACTIVE MOIETY495W7451VQCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92CHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-221CHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]2Legacy NDC, 2 package rows20191210_78209395-d854-477e-b097-89a5227638e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593450acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral SuspensionPSN78209395-d854-477e-b097-89a5227638e62
1593450acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SuspensionSCD78209395-d854-477e-b097-89a5227638e62
1593450acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SuspensionSY78209395-d854-477e-b097-89a5227638e62
1593450acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SuspensionSY78209395-d854-477e-b097-89a5227638e62
1593450APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SuspensionSY78209395-d854-477e-b097-89a5227638e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-221-18670910221181 BOTTLE in 1 CARTON (67091-221-18) > 118 mL in 1 BOTTLE1 bottle2014-12-120000-00-00NoNoCurrent