FDA.reportPublic FDA data

Rugby Chest Congestion Relief

Product NDC
71335-2216
11-digit product format
713352216
Labeler code
71335
Product ID
71335-2216_c9d9d4bf-2fb0-44d4-b3fa-b16457faf413
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide / Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/1; mg/1
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
Rugby Chest Congestion Relief
Brand name suffix
DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
GUAIFENESIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1147685

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
71335-2216-1Rugby Chest Congestion ReliefDM30 in 1 BOTTLETABLET30102
71335-2216-2Rugby Chest Congestion ReliefDM20 in 1 BOTTLETABLET20102
71335-2216-3Rugby Chest Congestion ReliefDM18 in 1 BOTTLETABLET18102
71335-2216-4Rugby Chest Congestion ReliefDM60 in 1 BOTTLETABLET60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2216RUGBY CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [BRYANT RANCH PREPACK]102Current NDC, 4 package rows20250228_7b23faa9-40c8-4cea-b9fb-487cce2664af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN7b23faa9-40c8-4cea-b9fb-487cce2664af102
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD7b23faa9-40c8-4cea-b9fb-487cce2664af102
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY7b23faa9-40c8-4cea-b9fb-487cce2664af102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2216-17133522160130 TABLET in 1 BOTTLE (71335-2216-1) 30 tablet2023-08-02NoNoHistorical
71335-2216-27133522160220 TABLET in 1 BOTTLE (71335-2216-2) 20 tablet2024-04-01NoNoHistorical
71335-2216-37133522160318 TABLET in 1 BOTTLE (71335-2216-3) 18 tablet2025-01-31NoNoHistorical
71335-2216-47133522160460 TABLET in 1 BOTTLE (71335-2216-4) 60 tablet2025-01-31NoNoHistorical