FDA.reportPublic FDA data

MAX Tussin Cough and Chest Congestion DM Sugar Free

Product NDC
17856-1126
11-digit product format
178561126
Labeler code
17856
Product ID
17856-1126_34f59881-a27e-6c09-e063-6394a90a619f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-15
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 mg/10mL; mg/10mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MAX Tussin Cough and Chest Congestion DM Sugar Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL
GUAIFENESIN200 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui996520

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1126-1MAX Tussin Cough and Chest Congestion DM Sugar Free72 in 1 BOX, UNIT-DOSELIQUID722
17856-1126-2MAX Tussin Cough and Chest Congestion DM Sugar Free72 in 1 BOX, UNIT-DOSELIQUID722
17856-1126-3MAX Tussin Cough and Chest Congestion DM Sugar Free5 mL in 1 CUP, UNIT-DOSELIQUID52
17856-1126-4MAX Tussin Cough and Chest Congestion DM Sugar Free10 mL in 1 CUP, UNIT-DOSELIQUID102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1126MAX TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ATLANTIC BIOLOGICALS CORP.]2Current NDC, 4 package rows20250514_8f496c61-41a6-41ba-80f5-7a5309c4d18b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN8f496c61-41a6-41ba-80f5-7a5309c4d18b2
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD8f496c61-41a6-41ba-80f5-7a5309c4d18b2
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY8f496c61-41a6-41ba-80f5-7a5309c4d18b2
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY8f496c61-41a6-41ba-80f5-7a5309c4d18b2
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY8f496c61-41a6-41ba-80f5-7a5309c4d18b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-1126-11785611260172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1126-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-1126-3) 2024-12-16NoNoCurrent
17856-1126-21785611260272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1126-2) / 10 mL in 1 CUP, UNIT-DOSE (17856-1126-4) 2024-12-16NoNoCurrent
17856-1126-3178561126035 mL in 1 CUP, UNIT-DOSE5 mlHistorical
17856-1126-41785611260410 mL in 1 CUP, UNIT-DOSE10 mlHistorical