FDA.reportPublic FDA data

MAX Tussin Cough and Chest Congestion DM

Product NDC
71399-0025
11-digit product format
713990025
Labeler code
71399
Product ID
71399-0025_422ca415-523c-ea9d-e063-6294a90aed02
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Akron Pharma Inc.
Application
M012
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
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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-0025-42025-03-10C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fMax Tussin Cough and Chest Congestion DM Guaifenesin 200mg and Dextromethorphan Hbr 20mg per 10ml Alcohol-Free Cherry Flavor
71399-0025-42025-03-10C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fDrug Facts
71399-0025-62025-03-10C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fMax Tussin Cough and Chest Congestion DM Guaifenesin 200mg and Dextromethorphan Hbr 20mg per 10ml Alcohol-Free Cherry Flavor
71399-0025-62025-03-10C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fDrug Facts
71399-0025-82025-03-10C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fMax Tussin Cough and Chest Congestion DM Guaifenesin 200mg and Dextromethorphan Hbr 20mg per 10ml Alcohol-Free Cherry Flavor
71399-0025-82025-03-10C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fDrug Facts
71399-0025-42025-01-30C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fMax Tussin Cough and Chest Congestion DM Guaifenesin 200mg and Dextromethorphan Hbr 20mg per 10ml Alcohol-Free Cherry Flavor
71399-0025-42025-01-30C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fDrug Facts
71399-0025-62025-01-30C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fMax Tussin Cough and Chest Congestion DM Guaifenesin 200mg and Dextromethorphan Hbr 20mg per 10ml Alcohol-Free Cherry Flavor
71399-0025-62025-01-30C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fDrug Facts
71399-0025-82025-01-30C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fMax Tussin Cough and Chest Congestion DM Guaifenesin 200mg and Dextromethorphan Hbr 20mg per 10ml Alcohol-Free Cherry Flavor
71399-0025-82025-01-30C16284748780-12cef2736-8bac-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0025-4MAX Tussin Cough and Chest Congestion DM1 in 1 PACKAGELIQUID14
71399-0025-4MAX Tussin Cough and Chest Congestion DM118 mL in 1 BOTTLE, PLASTICLIQUID1184
71399-0025-6MAX Tussin Cough and Chest Congestion DM473 mL in 1 BOTTLE, PLASTICLIQUID4734
71399-0025-8MAX Tussin Cough and Chest Congestion DM236 mL in 1 BOTTLE, PLASTICLIQUID2364
71399-0025-8MAX Tussin Cough and Chest Congestion DM1 in 1 PACKAGELIQUID14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0025-4ML - Milliliter71399-0025457cac6f-c02d-40ca-a0bd-6b77fa64ecb912023-06-06
71399-0025-6ML - Milliliter71399-0025177d8519-497c-41f1-b4a2-90665674799d12023-06-06
71399-0025-8ML - Milliliter71399-0025d93b3326-1235-4e08-bf6e-2d7e130afcb612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0025MAX TUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AKRON PHARMA INC.]2Current NDC, 5 package rows20250312_e0ce4287-bfa1-4413-97c8-4fe2e39bda36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNe0ce4287-bfa1-4413-97c8-4fe2e39bda364
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDe0ce4287-bfa1-4413-97c8-4fe2e39bda364
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYe0ce4287-bfa1-4413-97c8-4fe2e39bda364
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYe0ce4287-bfa1-4413-97c8-4fe2e39bda364
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYe0ce4287-bfa1-4413-97c8-4fe2e39bda364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-0025-4713990025041 BOTTLE, PLASTIC in 1 PACKAGE (71399-0025-4) / 118 mL in 1 BOTTLE, PLASTIC2023-05-15NoNoHistorical
71399-0025-671399002506473 mL in 1 BOTTLE, PLASTIC (71399-0025-6) 473 ml2023-05-15NoNoHistorical
71399-0025-8713990025081 BOTTLE, PLASTIC in 1 PACKAGE (71399-0025-8) / 236 mL in 1 BOTTLE, PLASTIC2023-05-15NoNoHistorical