FDA.reportPublic FDA data

Guaifenesin

Product NDC
69842-335
11-digit product format
698420335
Labeler code
69842
Product ID
69842-335_4653e896-cfea-4625-e063-6394a90a4c7f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2021-03-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin
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
69842-335-16Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE145
69842-335-28Guaifenesin28 in 1 BLISTER PACKTABLET, EXTENDED RELEASE285
69842-335-42Guaifenesin42 in 1 BLISTER PACKTABLET, EXTENDED RELEASE425

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-335GUAIFENESIN TABLET, EXTENDED RELEASE [CVS PHARMACY, INC]3Current NDC, Legacy NDC, 3 package rows20241120_bdaf7359-8698-87d6-e053-2a95a90ada28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNbdaf7359-8698-87d6-e053-2a95a90ada285
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDbdaf7359-8698-87d6-e053-2a95a90ada285
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYbdaf7359-8698-87d6-e053-2a95a90ada285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-335-166984203351614 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-16) 2021-03-010000-00-00NoNoCurrent
69842-335-286984203352828 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-28) 2021-03-010000-00-00NoNoCurrent
69842-335-426984203354242 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-42) 2021-03-010000-00-00NoNoCurrent