Guaifenesin

Product NDC
69618-061
11-digit product format
696180061
Labeler code
69618
Product ID
69618-061_2bc81e27-90e3-930d-e063-6394a90a699d
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-01
Substance
GUAIFENESIN
Active strength
400 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui359601

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-061-062023-03-29C16284748780-1f386c649-d238-0266-e053-dadaa90a7c1aGuifenisen 400 mg
69618-061-062023-01-30C16284748780-1f386c649-d238-0266-e053-dadaa90a7c1aGuifenisen 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-061-06Guaifenesin60 in 1 BOTTLE, PLASTICTABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-061-06EA - Each69618-0619467aaf0-ae81-4301-a553-1077f9182d4412021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-061GUAIFENESIN TABLET [RELIABLE 1 LABORATORIES LLC]5Current NDC, Legacy NDC, 1 package rows20250117_ae469d4f-91c4-cff0-e053-2995a90a0497.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSN570a71eb-2d19-4c7b-8c00-e1524bfa3844102
359601guaifenesin 400 MG Oral TabletSCD570a71eb-2d19-4c7b-8c00-e1524bfa3844102
359601guaiFENesin 400 MG Oral TabletPSNae469d4f-91c4-cff0-e053-2995a90a04975
359601guaifenesin 400 MG Oral TabletSCDae469d4f-91c4-cff0-e053-2995a90a04975

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69618-061-066961800610660 TABLET in 1 BOTTLE, PLASTIC (69618-061-06) 60 tablet2020-08-010000-00-00NoNoCurrent