FDA.reportPublic FDA data

Mucus Relief

Product NDC
70677-1051
11-digit product format
706771051
Labeler code
70677
Product ID
70677-1051_a908cf86-1d0c-4eda-b6ad-139775d3c355
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA207342
Marketing category
ANDA
Marketing start
2023-03-01
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1051-1Mucus Relief1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE11
70677-1051-1Mucus Relief14 in 1 CARTONTABLET, EXTENDED RELEASE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1051-1EA - Each70677-10515038d52f-cb4f-42b2-853a-75a4a884830512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1051MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 2 package rows20230404_cd7955b2-8eee-43d3-973f-6de2f3929512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNcd7955b2-8eee-43d3-973f-6de2f39295121
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDcd7955b2-8eee-43d3-973f-6de2f39295121
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYcd7955b2-8eee-43d3-973f-6de2f39295121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1051-17067710510114 BLISTER PACK in 1 CARTON (70677-1051-1) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK14 blister pack2023-03-01NoNoCurrent