Guaifenesin 200mg

Product NDC
69517-148
11-digit product format
695170148
Labeler code
69517
Product ID
69517-148_3cf7d8e6-a2ef-d0be-e063-6294a90a84ef
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
HEALTHLIFE OF USA LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-22
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
69517-148-03Guaifenesin 200mg300 in 1 BOTTLETABLET3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-148GUAIFENESIN 200MG (GUAIFENESIN) TABLET [HEALTHLIFE OF USA LLC]2Current NDC, Legacy NDC, 1 package rows20231021_d6aa1493-bc22-a318-e053-2995a90a6381.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197741guaiFENesin 200 MG Oral TabletPSNd6aa1493-bc22-a318-e053-2995a90a63814
197741guaifenesin 200 MG Oral TabletSCDd6aa1493-bc22-a318-e053-2995a90a63814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69517-148-0369517014803300 TABLET in 1 BOTTLE (69517-148-03) 300 tablet2025-08-220000-00-00NoNoCurrent