FDA.reportPublic FDA data

Rugby Chest Congestion Relief

Product NDC
0536-1312
11-digit product format
005361312
Labeler code
0536
Product ID
0536-1312_e93f67ff-29ce-4e47-8ca2-4a85d92a2772
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide / Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Rugby Laboratories
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
0536-1312-08Rugby Chest Congestion ReliefDM60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1312-08EA - Each0536-1312c5838f8c-3827-49d1-9774-f98f4dbeeade12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1312RUGBY CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [RUGBY LABORATORIES]5Current NDC, Legacy NDC, 1 package rows20241220_5da36516-9f94-49cb-9421-0c310abcd116.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
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN5da36516-9f94-49cb-9421-0c310abcd1165
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD5da36516-9f94-49cb-9421-0c310abcd1165
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY5da36516-9f94-49cb-9421-0c310abcd1165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1312-080053613120860 TABLET in 1 BOTTLE (0536-1312-08) 60 tablet2020-09-010000-00-00NoNoCurrent