FDA.reportPublic FDA data

Mucus Relief Extended Release

Product NDC
41520-731
11-digit product format
415200731
Labeler code
41520
Product ID
41520-731_6f2f767f-fc84-4ac1-86fc-e27f3d46819b
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Care One (American Sales Company)
Application
ANDA207342
Marketing category
ANDA
Marketing start
2018-12-31
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 Extended Release
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-731-202020-10-21C16284748780-1ab0e2407-2a9a-f274-e053-dbdaa90a6471Drug Facts
41520-731-202020-09-27C16284748780-1ab0e2407-2a9a-f274-e053-dbdaa90a6471Drug Facts
41520-731-202020-09-25C16284748780-1ab0e2407-2a9a-f274-e053-dbdaa90a6471Drug Facts
41520-731-202020-07-22C16284748780-1ab0e2407-2a9a-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-731-20Mucus Relief Extended Release1 in 1 BLISTER PACKTABLET13
41520-731-20Mucus Relief Extended Release20 in 1 CARTONTABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-731MUCUS RELIEF EXTENDED RELEASE (GUAIFENESIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]3Current NDC, Legacy NDC, 2 package rows20221122_96569c70-0936-4041-ab32-2b2262402f34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN96569c70-0936-4041-ab32-2b2262402f343
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD96569c70-0936-4041-ab32-2b2262402f343
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY96569c70-0936-4041-ab32-2b2262402f343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-731-204152007312020 BLISTER PACK in 1 CARTON (41520-731-20) / 1 TABLET in 1 BLISTER PACK20 blister pack2018-12-310000-00-00NoNoCurrent