Guaifenesin 200mg

Product NDC
10135-789
11-digit product format
101350789
Labeler code
10135
Product ID
10135-789_437e388b-2293-0064-e063-6394a90add05
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-01
Substance
GUAIFENESIN
Active strength
200 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
Guaifenesin 200mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui197741

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
10135-789-01Guaifenesin 200mg100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-789-01EA - Each10135-789601de2dd-3623-460f-9cb3-33bbcb48bb5e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-789GUAIFENESIN 200MG (GUAIFENESIN) TABLET [MARLEX PHARMACEUTICALS INC]1Current NDC, 1 package rows20240319_13b8f480-d1ac-d70c-e063-6394a90ab4f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197741guaiFENesin 200 MG Oral TabletPSN13b8f480-d1ac-d70c-e063-6394a90ab4f42
197741guaifenesin 200 MG Oral TabletSCD13b8f480-d1ac-d70c-e063-6394a90ab4f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10135-789-0110135078901100 TABLET in 1 BOTTLE (10135-789-01) 100 tablet2024-03-01NoNoHistorical