FDA.reportPublic FDA data

Mucus Relief

Product NDC
36800-932
11-digit product format
368000932
Labeler code
36800
Product ID
36800-932_acf97743-910f-4e3a-960b-18f949faa053
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
ANDA207342
Marketing category
ANDA
Marketing start
2019-03-31
Marketing end
2026-07-28
Substance
GUAIFENESIN
Active strength
1200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief
Brand name suffix
Maximum Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-932-142020-09-01C16284748780-1ab0e2407-32a7-f274-e053-dbdaa90a6471Drug Facts
36800-932-142020-07-22C16284748780-1ab0e2407-32a7-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-932-14Mucus ReliefMaximum Strength1 in 1 BLISTER PACKTABLET15
36800-932-14Mucus ReliefMaximum Strength14 in 1 CARTONTABLET145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-932-14EA - Each36800-93211910436-f28c-4c1c-a6c5-5997e849a6f112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-932MUCUS RELIEF MAXIMUM STRENGTH (GUAIFENESIN) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]4Current NDC, Legacy NDC, 2 package rows20221130_fd752112-30ea-409f-9621-726275c4fec1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNfd752112-30ea-409f-9621-726275c4fec15
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDfd752112-30ea-409f-9621-726275c4fec15
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYfd752112-30ea-409f-9621-726275c4fec15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-932-143680009321414 BLISTER PACK in 1 CARTON (36800-932-14) / 1 TABLET in 1 BLISTER PACK14 blister pack2019-03-312026-07-28NoNoCurrent