365 WHOLE FOODS MARKET GUAIFENESIN

Product NDC
42681-0057
11-digit product format
426810057
Labeler code
42681
Product ID
42681-0057_7c890031-8188-48be-bb69-06db0e01a0c0
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Whole Foods Market, Inc.
Application
ANDA210453
Marketing category
ANDA
Marketing start
2026-01-23
Substance
GUAIFENESIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
365 WHOLE FOODS MARKET GUAIFENESIN
Listing expiration
2027-12-31

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
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
42681-0057-1365 WHOLE FOODS MARKET GUAIFENESIN20 in 1 BOTTLETABLET, EXTENDED RELEASE201
42681-0057-1365 WHOLE FOODS MARKET GUAIFENESIN1 in 1 CARTONTABLET, EXTENDED RELEASE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN7c890031-8188-48be-bb69-06db0e01a0c01
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD7c890031-8188-48be-bb69-06db0e01a0c01
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY7c890031-8188-48be-bb69-06db0e01a0c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42681-0057-1426810057011 BOTTLE in 1 CARTON (42681-0057-1) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2026-01-23NoNoHistorical