FDA.reportPublic FDA data

Tussi Pres

Product NDC
52083-231
11-digit product format
520830231
Labeler code
52083
Product ID
52083-231_15192bad-05a9-4d18-9604-db4122f47aad
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Kramer Novis
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-28
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 200; 5 mg/5mL; mg/5mL; mg/5mL
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
Tussi Pres
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN200 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1098647

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
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
52083-231-042025-11-18C16284748780-12cef2736-8bbc-d83d-e063-dadaa90ab31fTUSSI-PRES
52083-231-102025-11-18C16284748780-12cef2736-8bbc-d83d-e063-dadaa90ab31fTUSSI-PRES
52083-231-162025-11-18C16284748780-12cef2736-8bbc-d83d-e063-dadaa90ab31fTUSSI-PRES
52083-231-042025-01-30C16284748780-12cef2736-8bbc-d83d-e063-dadaa90ab31fTUSSI-PRES
52083-231-102025-01-30C16284748780-12cef2736-8bbc-d83d-e063-dadaa90ab31fTUSSI-PRES
52083-231-162025-01-30C16284748780-12cef2736-8bbc-d83d-e063-dadaa90ab31fTUSSI-PRES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-231-04Tussi Pres120 mL in 1 BOTTLESYRUP1205
52083-231-10Tussi Pres10 mL in 1 PACKETSYRUP105
52083-231-16Tussi Pres480 mL in 1 BOTTLESYRUP4805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-231-04ML - Milliliter52083-2310d927646-59e4-4cbc-aca6-1231215f46ab12012-07-24
52083-231-10ML - Milliliter52083-231425c0a76-d6cd-49c0-b985-610536b7542912013-02-13
52083-231-16ML - Milliliter52083-2317aff57c5-ff9e-4382-ae31-880dd2da30b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-231TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]4Current NDC, Legacy NDC, 3 package rows20221102_0d4ee530-2a5c-41a0-88bf-ac92d538661b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098647dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSN0d4ee530-2a5c-41a0-88bf-ac92d538661b5
1098647dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD0d4ee530-2a5c-41a0-88bf-ac92d538661b5
1098647dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY0d4ee530-2a5c-41a0-88bf-ac92d538661b5
1098647dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSY0d4ee530-2a5c-41a0-88bf-ac92d538661b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-231-0452083023104120 mL in 1 BOTTLE120 mlHistorical
52083-231-105208302311010 mL in 1 PACKET (52083-231-10) 10 ml2011-03-280000-00-00NoNoCurrent
52083-231-1652083023116480 mL in 1 BOTTLE (52083-231-16) 480 ml2011-03-280000-00-00NoNoCurrent