FDA.reportPublic FDA data

Tussin Mucus and Chest Congestion Sugar Free

Product NDC
82568-0012
11-digit product format
825680012
Labeler code
82568
Product ID
82568-0012_86b38bae-a0d7-48cd-a7ba-ceb5e2a719cf
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
AARNA USA, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-18
Substance
GUAIFENESIN
Active strength
200 mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310604

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82568-0012-4Tussin Mucus and Chest Congestion Sugar Free118 mL in 1 BOTTLE, PLASTICLIQUID1181
82568-0012-4Tussin Mucus and Chest Congestion Sugar Free1 in 1 PACKAGELIQUID11
82568-0012-6Tussin Mucus and Chest Congestion Sugar Free473 mL in 1 BOTTLE, PLASTICLIQUID4731
82568-0012-8Tussin Mucus and Chest Congestion Sugar Free1 in 1 PACKAGELIQUID11
82568-0012-8Tussin Mucus and Chest Congestion Sugar Free236 mL in 1 BOTTLE, PLASTICLIQUID2361

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0012-4ML - Milliliter82568-0012a393c961-6b94-44a4-afa4-8e120468d24d12025-05-14
82568-0012-6ML - Milliliter82568-001239537577-7cd3-44a1-b4e2-98347b606fa912025-05-14
82568-0012-8ML - Milliliter82568-001214c90c97-9f31-4c2a-acbf-201a5418d79f12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82568-0012TUSSIN MUCUS AND CHEST CONGESTION SUGAR FREE (GUAIFENESIN) LIQUID [AARNA USA, INC.]1Current NDC, 5 package rows20250228_6e488782-0138-436d-a9f0-0ec5bc9daedd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN6e488782-0138-436d-a9f0-0ec5bc9daedd1
310604guaifenesin 20 MG/ML Oral SolutionSCD6e488782-0138-436d-a9f0-0ec5bc9daedd1
310604guaifenesin 100 MG per 5 ML Oral SolutionSY6e488782-0138-436d-a9f0-0ec5bc9daedd1
310604guaifenesin 100 MG per 5 ML Oral SyrupSY6e488782-0138-436d-a9f0-0ec5bc9daedd1
310604guaifenesin 200 MG per 10 ML Oral SolutionSY6e488782-0138-436d-a9f0-0ec5bc9daedd1
310604guaifenesin 300 MG per 15 ML Oral SolutionSY6e488782-0138-436d-a9f0-0ec5bc9daedd1
310604guaifenesin 400 MG per 20 ML Oral SolutionSY6e488782-0138-436d-a9f0-0ec5bc9daedd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82568-0012-4825680012041 BOTTLE, PLASTIC in 1 PACKAGE (82568-0012-4) / 118 mL in 1 BOTTLE, PLASTIC2025-02-18NoNoHistorical
82568-0012-682568001206473 mL in 1 BOTTLE, PLASTIC (82568-0012-6) 473 ml2025-02-18NoNoHistorical
82568-0012-8825680012081 BOTTLE, PLASTIC in 1 PACKAGE (82568-0012-8) / 236 mL in 1 BOTTLE, PLASTIC2025-02-18NoNoHistorical