FDA.reportPublic FDA data

Mucus Relief Extended Release

Product NDC
0536-1163
11-digit product format
005361163
Labeler code
0536
Product ID
0536-1163_ed6550fd-e566-47aa-9de7-f3245592b45c
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rugby Laboratories, Inc.
Application
ANDA207342
Marketing category
ANDA
Marketing start
2018-08-31
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
Mucus Relief Extended Release
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
0536-1163-61Mucus Relief Extended Release100 in 1 CARTONTABLET, EXTENDED RELEASE1005
0536-1163-61Mucus Relief Extended Release1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1163-61EA - Each0536-1163b1e5fd9f-0312-436c-b65b-d5b4531febf512018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1163MUCUS RELIEF EXTENDED RELEASE (GUAIFENESIN) TABLET, EXTENDED RELEASE [RUGBY LABORATORIES, INC.]5Current NDC, Legacy NDC, 2 package rows20250501_8bc6f08e-a941-4fa8-8dd6-a699abf2337d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN8bc6f08e-a941-4fa8-8dd6-a699abf2337d5
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD8bc6f08e-a941-4fa8-8dd6-a699abf2337d5
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY8bc6f08e-a941-4fa8-8dd6-a699abf2337d5
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNf4c1e725-bcae-2255-e053-2995a90ad3352
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDf4c1e725-bcae-2255-e053-2995a90ad3352
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYf4c1e725-bcae-2255-e053-2995a90ad3352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1163-6100536116361100 BLISTER PACK in 1 CARTON (0536-1163-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2018-08-310000-00-00NoNoCurrent