FDA.reportPublic FDA data

Mucus Relief ER

Product NDC
0536-1249
11-digit product format
005361249
Labeler code
0536
Product ID
0536-1249_3b5fbc86-cb0e-468d-e063-6394a90a811f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA217780
Marketing category
ANDA
Marketing start
2025-04-21
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 ER
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
0536-1249-71Mucus Relief ER14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE144
0536-1249-71Mucus Relief ER2 in 1 CARTONTABLET, EXTENDED RELEASE24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1249-71EA - Each0536-1249ad5300e8-fed6-4628-b549-8fab9bff293e12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1249MUCUS RELIEF ER (GUAIFENESIN) TABLET, EXTENDED RELEASE [RUGBY LABORATORIES]2Current NDC, 2 package rows20250422_2e6901aa-16f6-9b73-e063-6294a90a4d72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN2e6901aa-16f6-9b73-e063-6294a90a4d724
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD2e6901aa-16f6-9b73-e063-6294a90a4d724
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY2e6901aa-16f6-9b73-e063-6294a90a4d724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0536-1249-71005361249712 BLISTER PACK in 1 CARTON (0536-1249-71) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2025-04-21NoNoHistorical