FDA.reportPublic FDA data

Mucus Relief

Product NDC
71610-499
11-digit product format
716100499
Labeler code
71610
Product ID
71610-499_349de2f9-ec60-43d7-990a-074c673aa7e3
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA209215
Marketing category
ANDA
Marketing start
2019-09-23
Substance
GUAIFENESIN
Active strength
600 mg/1
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-499-12Mucus Relief12 in 1 BOTTLETABLET, EXTENDED RELEASE122
71610-499-53Mucus Relief60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-499-12EA - Each71610-4993e2e8649-bef3-455d-a1f1-69091b1f556512021-07-15
71610-499-53EA - Each71610-4996a373220-5cfb-4e9f-8838-955b95fc5e6812021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-499MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20210504_01af03f1-5d1b-4893-b7db-7092ba66e842.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN01af03f1-5d1b-4893-b7db-7092ba66e8422
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD01af03f1-5d1b-4893-b7db-7092ba66e8422
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY01af03f1-5d1b-4893-b7db-7092ba66e8422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-499-127161004991212 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-12) 2021-04-160000-00-00NoNoCurrent
71610-499-537161004995360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-53) 2020-11-200000-00-00NoNoCurrent