Mucus Relief

Product NDC
36800-137
11-digit product format
368000137
Labeler code
36800
Product ID
36800-137_4f9ad2e4-d72c-4d70-bdce-470919a58df0
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
ANDA207342
Marketing category
ANDA
Marketing start
2019-03-31
Marketing end
2026-07-28
Substance
GUAIFENESIN
Active strength
600 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
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-137-202020-11-10C16284748780-1ab0e2407-32a4-f274-e053-dbdaa90a6471Drug Facts
36800-137-202020-09-27C16284748780-1ab0e2407-32a4-f274-e053-dbdaa90a6471Drug Facts
36800-137-202020-09-25C16284748780-1ab0e2407-32a4-f274-e053-dbdaa90a6471Drug Facts
36800-137-202020-07-22C16284748780-1ab0e2407-32a4-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-137-20Mucus Relief1 in 1 BLISTER PACKTABLET15
36800-137-20Mucus Relief20 in 1 CARTONTABLET205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-137MUCUS RELIEF (GUAIFENESIN) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]4Current NDC, Legacy NDC, 2 package rows20221130_1d29055d-3712-42b1-a6a2-f86032179a17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN1d29055d-3712-42b1-a6a2-f86032179a175
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD1d29055d-3712-42b1-a6a2-f86032179a175
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY1d29055d-3712-42b1-a6a2-f86032179a175

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-137-203680001372020 BLISTER PACK in 1 CARTON (36800-137-20) / 1 TABLET in 1 BLISTER PACK20 blister pack2019-03-312026-07-28NoNoCurrent