Mucus Relief

Product NDC
0536-1392
11-digit product format
005361392
Labeler code
0536
Product ID
0536-1392_2084ed1b-b468-48d7-bdb1-587fc6e5fd50
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA207342
Marketing category
ANDA
Marketing start
2023-07-01
Marketing end
2026-10-28
Substance
GUAIFENESIN
Active strength
1200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1392-88Mucus Relief1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE13
0536-1392-88Mucus Relief14 in 1 CARTONTABLET, EXTENDED RELEASE143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1392-88EA - Each0536-1392a45d4854-be7d-4fee-8774-5a605861189d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1392MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [RUGBY LABORATORIES, INC.]2Current NDC, 2 package rows20250207_ee413595-2687-4c38-84ce-18aac933d8e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNee413595-2687-4c38-84ce-18aac933d8e33
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDee413595-2687-4c38-84ce-18aac933d8e33
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYee413595-2687-4c38-84ce-18aac933d8e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1392-880053613928814 BLISTER PACK in 1 CARTON (0536-1392-88) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK14 blister pack2023-07-012026-10-28NoNoHistorical