FDA.reportPublic FDA data

foster and thrive mucus relief

Product NDC
70677-1291
11-digit product format
706771291
Labeler code
70677
Product ID
70677-1291_f1a23f52-3c0e-4c0b-b0cd-75de52ffde51
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA078912
Marketing category
ANDA
Marketing start
2025-05-21
Substance
GUAIFENESIN
Active strength
600 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
foster and thrive 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
70677-1291-1foster and thrive mucus relief5 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL52
70677-1291-1foster and thrive mucus relief20 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1291-1EA - Each70677-1291c2704f8f-6094-4bcc-981b-d44d6ceb388012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1291FOSTER AND THRIVE MUCUS RELIEF (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20250523_b875dc68-931c-4329-ab61-83347884aaeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNb875dc68-931c-4329-ab61-83347884aaeb2
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDb875dc68-931c-4329-ab61-83347884aaeb2
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYb875dc68-931c-4329-ab61-83347884aaeb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1291-1706771291015 BLISTER PACK in 1 CARTON (70677-1291-1) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK5 blister pack2025-05-21NoNoHistorical