FDA.reportPublic FDA data

tussin cough chest congestion

Product NDC
11822-1332
11-digit product format
118221332
Labeler code
11822
Product ID
11822-1332_406f624c-add2-47d6-a895-fbdef9883388
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Rite Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-02
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 cough chest congestion
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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1332-1tussin cough chest congestion1 in 1 CARTONSOLUTION13
11822-1332-1tussin cough chest congestion118 mL in 1 BOTTLESOLUTION1183
11822-1332-2tussin cough chest congestion1 in 1 CARTONSOLUTION13
11822-1332-2tussin cough chest congestion237 mL in 1 BOTTLESOLUTION2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1332TUSSIN COUGH CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [RITE AID CORPORATION]3Current NDC, 4 package rows20241110_86fc3723-5fc5-4de5-bd04-7774c2abe539.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN86fc3723-5fc5-4de5-bd04-7774c2abe5393
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD86fc3723-5fc5-4de5-bd04-7774c2abe5393
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY86fc3723-5fc5-4de5-bd04-7774c2abe5393
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY86fc3723-5fc5-4de5-bd04-7774c2abe5393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11822-1332-1118221332011 BOTTLE in 1 CARTON (11822-1332-1) / 118 mL in 1 BOTTLE1 bottle2023-03-02NoNoHistorical
11822-1332-2118221332021 BOTTLE in 1 CARTON (11822-1332-2) / 237 mL in 1 BOTTLE1 bottle2023-03-02NoNoHistorical