FDA.reportPublic FDA data

Mucus Relief

Product NDC
83324-097
11-digit product format
833240097
Labeler code
83324
Product ID
83324-097_1d8b86fb-a098-f75c-e063-6394a90a200d
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
ANDA213420
Marketing category
ANDA
Marketing start
2024-07-18
Substance
GUAIFENESIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

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
83324-097-20Mucus Relief20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE202
83324-097-20Mucus Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-097-20EA - Each83324-097a4f180d0-43d0-49c1-9fee-106f2802a22f12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-097MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 2 package rows20240719_b630357a-4166-4b30-8137-47ca3d579e79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNb630357a-4166-4b30-8137-47ca3d579e792
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDb630357a-4166-4b30-8137-47ca3d579e792
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYb630357a-4166-4b30-8137-47ca3d579e792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-097-20833240097201 BLISTER PACK in 1 CARTON (83324-097-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2024-07-18NoNoHistorical