Flu Relief Therapy

Product NDC
36800-317
11-digit product format
368000317
Labeler code
36800
Product ID
36800-317_50a1e4d6-f99d-4f7f-877e-f26803460704
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-31
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 25; 10 mg/30mL; mg/30mL; mg/30mL
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-317-08Flu Relief TherapyNighttime245 mL in 1 BOTTLE, PLASTICLIQUID2455

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
MALTITOLINACTIVE INGREDIENTD65DG142WKFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
WATERINACTIVE INGREDIENT059QF0KO0RFLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-317FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]5Current NDC, Legacy NDC, 1 package rows20231014_ed063755-6bdc-479a-92ab-04120350434d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-317-0836800031708245 mL in 1 BOTTLE, PLASTIC (36800-317-08) 245 ml2015-08-310000-00-00NoNoCurrent