FDA.reportPublic FDA data

Tussin DM

Product NDC
70677-1261
11-digit product format
706771261
Labeler code
70677
Product ID
70677-1261_006eaabd-8fdc-4e60-a130-306196057033
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-26
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tussin DM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN200 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1790650

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1261-1Tussin DM118 mL in 1 BOTTLE, PLASTICSOLUTION1184
70677-1261-1Tussin DM1 in 1 CARTONSOLUTION14
70677-1261-2Tussin DM1 in 1 CARTONSOLUTION14
70677-1261-2Tussin DM237 mL in 1 BOTTLE, PLASTICSOLUTION2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1261-1ML - Milliliter70677-1261d8224679-e9fd-4cd9-8740-094dd330b5aa12025-03-04
70677-1261-2ML - Milliliter70677-126190caf94a-0c86-4cb7-bd79-7142103fb30f12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1261TUSSIN DM (DEXTROMETHORPHAN HBR GUAIFENESIN) SOLUTION [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 4 package rows20250228_84750bfb-9e94-40a3-b731-21799f5e4fd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSN84750bfb-9e94-40a3-b731-21799f5e4fd14
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCD84750bfb-9e94-40a3-b731-21799f5e4fd14
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSY84750bfb-9e94-40a3-b731-21799f5e4fd14
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSY84750bfb-9e94-40a3-b731-21799f5e4fd14
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSY84750bfb-9e94-40a3-b731-21799f5e4fd14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70677-1261-1706771261011 BOTTLE, PLASTIC in 1 CARTON (70677-1261-1) / 118 mL in 1 BOTTLE, PLASTIC2025-02-26NoNoHistorical
70677-1261-2706771261021 BOTTLE, PLASTIC in 1 CARTON (70677-1261-2) / 237 mL in 1 BOTTLE, PLASTIC2025-02-26NoNoHistorical