FDA.reportPublic FDA data

Equate Mucus Relief

Product NDC
49035-284
11-digit product format
490350284
Labeler code
49035
Product ID
49035-284_516c76ac-5e2d-41f9-81bd-20e05f0b2300
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores, Inc.
Application
ANDA209215
Marketing category
ANDA
Marketing start
2024-04-09
Substance
GUAIFENESIN
Active strength
1200 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
Equate Mucus Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

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
49035-284-48Equate Mucus Relief48 in 1 BLISTER PACKTABLET, EXTENDED RELEASE481
49035-284-48Equate Mucus Relief2 in 1 CARTONTABLET, EXTENDED RELEASE21
49035-284-58Equate Mucus Relief1 in 1 CARTONTABLET, EXTENDED RELEASE11
49035-284-58Equate Mucus Relief14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-284EQUATE MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [WAL-MART STORES, INC.]1Current NDC, 4 package rows20240410_516c76ac-5e2d-41f9-81bd-20e05f0b2300.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN516c76ac-5e2d-41f9-81bd-20e05f0b23001
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD516c76ac-5e2d-41f9-81bd-20e05f0b23001
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY516c76ac-5e2d-41f9-81bd-20e05f0b23001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49035-284-48490350284482 BLISTER PACK in 1 CARTON (49035-284-48) / 48 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2024-04-09NoNoCurrent
49035-284-58490350284581 BLISTER PACK in 1 CARTON (49035-284-58) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2024-04-09NoNoCurrent