FDA.reportPublic FDA data

Mucus Relief

Product NDC
55319-733
11-digit product format
553190733
Labeler code
55319
Product ID
55319-733_04faab7f-35d0-48b8-88b4-5895a4b8c0e4
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
ANDA207342
Marketing category
ANDA
Marketing start
2025-04-01
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207342-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11
A207342-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefGUAIFENESINFamily Dollar (FAMILY WELLNESS)ddc18f31-acb2-4305-929a-f4746efd42242025-10-24WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use for children under 12 years of age. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Additional Listing Data#

Finished product
Yes
Brand name base
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
55319-733-14Mucus Relief1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE13
55319-733-14Mucus Relief14 in 1 CARTONTABLET, EXTENDED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-733MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [FAMILY DOLLAR (FAMILY WELLNESS)]2Current NDC, 2 package rows20250402_ddc18f31-acb2-4305-929a-f4746efd4224.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNddc18f31-acb2-4305-929a-f4746efd42243
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDddc18f31-acb2-4305-929a-f4746efd42243
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYddc18f31-acb2-4305-929a-f4746efd42243

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-733-145531907331414 BLISTER PACK in 1 CARTON (55319-733-14) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK14 blister pack2025-04-01NoNoCurrent