FDA.reportPublic FDA data

tussin

Product NDC
21130-707
11-digit product format
211300707
Labeler code
21130
Product ID
21130-707_8e25becd-a7f8-4f7f-9572-5ff6eb2a59f9
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Safeway
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-15
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/20mL; mg/20mL
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
tussin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1020138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-707-26tussin118 mL in 1 BOTTLESOLUTION1182
21130-707-26tussin1 in 1 CARTONSOLUTION12
21130-707-34tussin237 mL in 1 BOTTLESOLUTION2372
21130-707-34tussin1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-707TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SAFEWAY]2Current NDC, 4 package rows20241027_cf04bdf7-fed4-4f06-a193-f2e83fcc531c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNcf04bdf7-fed4-4f06-a193-f2e83fcc531c2
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDcf04bdf7-fed4-4f06-a193-f2e83fcc531c2
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYcf04bdf7-fed4-4f06-a193-f2e83fcc531c2
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYcf04bdf7-fed4-4f06-a193-f2e83fcc531c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-707-26211300707261 BOTTLE in 1 CARTON (21130-707-26) / 118 mL in 1 BOTTLE1 bottle2024-10-15NoNoCurrent
21130-707-34211300707341 BOTTLE in 1 CARTON (21130-707-34) / 237 mL in 1 BOTTLE1 bottle2024-10-22NoNoCurrent