FDA.reportPublic FDA data

Tussnex FM Cold, Flu and Sore Throat

Product NDC
53041-618
11-digit product format
530410618
Labeler code
53041
Product ID
53041-618_2bf14ba7-0b95-484f-bdee-d831f1f0cbe1
Type
HUMAN OTC DRUG
Nonproprietary name
Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Guardian Drug Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-12-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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
Tussnex FM Cold, Flu and Sore Throat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1116572

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-618-58Tussnex FM Cold, Flu and Sore Throat177 mL in 1 CARTONLIQUID1774

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92TUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
SORBITOLINACTIVE INGREDIENT506T60A25RTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-618TUSSNEX FM COLD, FLU AND SORE THROAT (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]4Current NDC, Legacy NDC, 1 package rows20241222_7bddce11-c227-4d95-94c1-6f41ecd7285b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN7bddce11-c227-4d95-94c1-6f41ecd7285b4
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD7bddce11-c227-4d95-94c1-6f41ecd7285b4
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY7bddce11-c227-4d95-94c1-6f41ecd7285b4
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY7bddce11-c227-4d95-94c1-6f41ecd7285b4
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY7bddce11-c227-4d95-94c1-6f41ecd7285b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53041-618-5853041061858177 mL in 1 CARTON (53041-618-58) 177 ml2012-12-010000-00-00NoNoCurrent