FDA.reportPublic FDA data

Tussin CF

Product NDC
70677-1187
11-digit product format
706771187
Labeler code
70677
Product ID
70677-1187_2b1ddb46-8ca9-5e1c-e063-6294a90a6b77
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr Guaifenesin Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services
Application
part341
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-09
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20; 200; 10 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tussin CF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL
GUAIFENESIN200 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1044949

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1187-1Tussin CF1 in 1 CARTONSOLUTION12
70677-1187-1Tussin CF237 mL in 1 BOTTLESOLUTION2372

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1187-1ML - Milliliter70677-1187ec31015c-5927-496d-8415-e1e2bad3c45012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1187TUSSIN CF (DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL) SOLUTION [STRATEGIC SOURCING SERVICES]2Current NDC, 2 package rows20250109_e416982f-6cbb-4f48-a215-16bea8393dad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044949dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSNe416982f-6cbb-4f48-a215-16bea8393dad2
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDe416982f-6cbb-4f48-a215-16bea8393dad2
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYe416982f-6cbb-4f48-a215-16bea8393dad2
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSYe416982f-6cbb-4f48-a215-16bea8393dad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1187-1706771187011 BOTTLE in 1 CARTON (70677-1187-1) / 237 mL in 1 BOTTLE1 bottle2023-08-09NoNoCurrent