FDA.reportPublic FDA data

Rugby Mucus and Chest Congestion 541

Product NDC
0536-1430
11-digit product format
005361430
Labeler code
0536
Product ID
0536-1430_0c07f9eb-4c55-4786-a2d8-bfc588e6fa2f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Rugby Laboratories
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-15
Substance
GUAIFENESIN
Active strength
200 mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rugby Mucus and Chest Congestion 541
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui1606850

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1430-97Rugby Mucus and Chest Congestion 541118 mL in 1 BOTTLELIQUID1182
0536-1430-97Rugby Mucus and Chest Congestion 5411 in 1 CARTONLIQUID12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1430-97ML - Milliliter0536-1430e1fb727b-b1a8-424b-bcba-60bec824392e12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1430RUGBY MUCUS AND CHEST CONGESTION 541 (GUAIFENESIN) LIQUID [RUGBY LABORATORIES]1Current NDC, 2 package rows20240517_76472912-b66f-4bb4-937a-4a589683a78c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1606850guaiFENesin 200 MG in 10 mL Oral SuspensionPSN76472912-b66f-4bb4-937a-4a589683a78c2
1606850guaifenesin 20 MG/ML Oral SuspensionSCD76472912-b66f-4bb4-937a-4a589683a78c2
1606850guaifenesin 200 MG per 10 ML Oral SuspensionSY76472912-b66f-4bb4-937a-4a589683a78c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0536-1430-97005361430971 BOTTLE in 1 CARTON (0536-1430-97) / 118 mL in 1 BOTTLE1 bottle2024-05-15NoNoHistorical