FDA.reportPublic FDA data

Leader Mucus Relief

Product NDC
70000-0721
11-digit product format
700000721
Labeler code
70000
Product ID
70000-0721_55cc203b-af6e-4cff-8cca-03892735b479
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA078912
Marketing category
ANDA
Marketing start
2025-03-09
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
Leader 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
70000-0721-1Leader Mucus Relief2 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL22
70000-0721-1Leader Mucus Relief7 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL72

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0721-1EA - Each70000-07216e67571e-5827-4742-aad6-5854475b09c712025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0721LEADER MUCUS RELIEF (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]2Current NDC, 2 package rows20250312_34981e01-f405-4feb-807b-3a8c02faca96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN34981e01-f405-4feb-807b-3a8c02faca962
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD34981e01-f405-4feb-807b-3a8c02faca962
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY34981e01-f405-4feb-807b-3a8c02faca962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0721-1700000721012 BLISTER PACK in 1 CARTON (70000-0721-1) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2025-03-09NoNoHistorical