Mucus Relief ER

Product NDC
0904-6718
11-digit product format
009046718
Labeler code
0904
Product ID
0904-6718_ebcfe516-e74c-4f97-8ade-85cfbadf4f33
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA207342
Marketing category
ANDA
Marketing start
2018-09-30
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 ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6718-39Mucus Relief ER1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE16
0904-6718-39Mucus Relief ER100 in 1 CARTONTABLET, EXTENDED RELEASE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6718-39EA - Each0904-6718d92d08de-0344-44fe-b4c0-e7f1ab2254bd12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6718MUCUS RELIEF ER (GUAIFENESIN) TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20250313_e5a242bf-3008-4c92-a930-e76f733be5cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNe5a242bf-3008-4c92-a930-e76f733be5cf6
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDe5a242bf-3008-4c92-a930-e76f733be5cf6
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYe5a242bf-3008-4c92-a930-e76f733be5cf6
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNf7abc2ff-21bc-48b5-9989-c5ac84f5c9cd5
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDf7abc2ff-21bc-48b5-9989-c5ac84f5c9cd5
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYf7abc2ff-21bc-48b5-9989-c5ac84f5c9cd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6718-3900904671839100 BLISTER PACK in 1 CARTON (0904-6718-39) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2018-09-300000-00-00NoNoCurrent