FDA.reportPublic FDA data

SDA Laboratories Tussin

Product NDC
66424-563
11-digit product format
664240563
Labeler code
66424
Product ID
66424-563_2a4460d2-5709-4e1f-e063-6294a90af814
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
SDA Laboratories, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
GUAIFENESIN
Active strength
100 mg/5mL
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
SDA Laboratories Tussin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310604

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
66424-563-16SDA Laboratories Tussin473 mL in 1 BOTTLELIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66424-563SDA LABORATORIES TUSSIN (GUAIFENESIN) LIQUID [SDA LABORATORIES, INC.]1Current NDC, 1 package rows20241228_2a444cc8-96be-9432-e063-6394a90a1b63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN2a444cc8-96be-9432-e063-6394a90a1b631
310604guaifenesin 20 MG/ML Oral SolutionSCD2a444cc8-96be-9432-e063-6394a90a1b631
310604guaifenesin 100 MG per 5 ML Oral SolutionSY2a444cc8-96be-9432-e063-6394a90a1b631
310604guaifenesin 100 MG per 5 ML Oral SyrupSY2a444cc8-96be-9432-e063-6394a90a1b631
310604guaifenesin 200 MG per 10 ML Oral SolutionSY2a444cc8-96be-9432-e063-6394a90a1b631
310604guaifenesin 300 MG per 15 ML Oral SolutionSY2a444cc8-96be-9432-e063-6394a90a1b631
310604guaifenesin 400 MG per 20 ML Oral SolutionSY2a444cc8-96be-9432-e063-6394a90a1b631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66424-563-1666424056316473 mL in 1 BOTTLE (66424-563-16) 473 ml2024-12-01NoNoCurrent