FDA.reportPublic FDA data

Mucus Relief Extended Release

Product NDC
0363-0832
11-digit product format
003630832
Labeler code
0363
Product ID
0363-0832_f351ee19-2a55-426f-b985-760e25c598eb
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA207342
Marketing category
ANDA
Marketing start
2018-08-31
Marketing end
2026-12-31
Substance
GUAIFENESIN
Active strength
1200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0832-14Mucus Relief Extended ReleaseMaximum Strength1 in 1 BLISTER PACKTABLET15
0363-0832-14Mucus Relief Extended ReleaseMaximum Strength14 in 1 CARTONTABLET145
0363-0832-28Mucus Relief Extended ReleaseMaximum Strength1 in 1 BLISTER PACKTABLET15
0363-0832-28Mucus Relief Extended ReleaseMaximum Strength28 in 1 CARTONTABLET285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0832MUCUS RELIEF EXTENDED RELEASE MAXIMUM STRENGTH (GUAIFENESIN) TABLET [WALGREENS]4Current NDC, Legacy NDC, 4 package rows20220527_e4b27b9b-5f3b-4314-9717-54d73cf6b74e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNe4b27b9b-5f3b-4314-9717-54d73cf6b74e5
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDe4b27b9b-5f3b-4314-9717-54d73cf6b74e5
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYe4b27b9b-5f3b-4314-9717-54d73cf6b74e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0832-140036308321414 BLISTER PACK in 1 CARTON (0363-0832-14) / 1 TABLET in 1 BLISTER PACK14 blister pack2018-08-312026-12-31NoNoCurrent
0363-0832-280036308322828 BLISTER PACK in 1 CARTON (0363-0832-28) / 1 TABLET in 1 BLISTER PACK28 blister pack2018-08-312026-12-31NoNoCurrent