FDA.reportPublic FDA data

basic care mucus er

Product NDC
72288-298
11-digit product format
722880298
Labeler code
72288
Product ID
72288-298_ca339682-ad63-4580-a252-1f464d64d2cf
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA078912
Marketing category
ANDA
Marketing start
2021-01-14
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
basic care mucus er
Listing expiration
2026-12-31

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
72288-298-02basic care mucus er5 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL55
72288-298-02basic care mucus er20 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL205
72288-298-33basic care mucus er60 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL605
72288-298-33basic care mucus er1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL15
72288-298-60basic care mucus er20 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL205
72288-298-60basic care mucus er1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-298BASIC CARE MUCUS ER (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [AMAZON.COM SERVICES LLC]5Current NDC, Legacy NDC, 6 package rows20220428_14213a15-5842-456f-a5ab-654268c58f78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN14213a15-5842-456f-a5ab-654268c58f785
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD14213a15-5842-456f-a5ab-654268c58f785
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY14213a15-5842-456f-a5ab-654268c58f785

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-298-02722880298025 BLISTER PACK in 1 CARTON (72288-298-02) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK5 blister pack2021-10-210000-00-00NoNoCurrent
72288-298-33722880298331 BOTTLE in 1 CARTON (72288-298-33) / 60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-01-140000-00-00NoNoCurrent
72288-298-60722880298601 BOTTLE in 1 CARTON (72288-298-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-08-200000-00-00NoNoCurrent