FDA.reportPublic FDA data

Mucus Relief

Product NDC
41520-732
11-digit product format
415200732
Labeler code
41520
Product ID
41520-732_72cc5e09-dd68-4158-935a-4fa739235045
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
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
Mucus Relief
Brand name suffix
Maximum Strength
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-732-142020-10-21C16284748780-1ab0e2407-2c73-f274-e053-dbdaa90a6471Drug Facts
41520-732-142020-09-27C16284748780-1ab0e2407-2c73-f274-e053-dbdaa90a6471Drug Facts
41520-732-142020-09-25C16284748780-1ab0e2407-2c73-f274-e053-dbdaa90a6471Drug Facts
41520-732-142020-07-22C16284748780-1ab0e2407-2c73-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-732-14Mucus ReliefMaximum Strength1 in 1 BLISTER PACKTABLET13
41520-732-14Mucus ReliefMaximum Strength14 in 1 CARTONTABLET143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-732MUCUS RELIEF MAXIMUM STRENGTH (GUAIFENESIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]3Current NDC, Legacy NDC, 2 package rows20221122_c94e3943-20da-4bd4-b0ff-6aa60b03a1bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNc94e3943-20da-4bd4-b0ff-6aa60b03a1bf3
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDc94e3943-20da-4bd4-b0ff-6aa60b03a1bf3
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYc94e3943-20da-4bd4-b0ff-6aa60b03a1bf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-732-144152007321414 BLISTER PACK in 1 CARTON (41520-732-14) / 1 TABLET in 1 BLISTER PACK14 blister pack2018-12-310000-00-00NoNoCurrent