FDA.reportPublic FDA data

basic care mucus er max

Product NDC
72288-650
11-digit product format
722880650
Labeler code
72288
Product ID
72288-650_bb560851-9ea3-4e85-9053-0a4f57c67b66
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2021-08-11
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
basic care mucus er max
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
72288-650-02basic care mucus er max3 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL33
72288-650-02basic care mucus er max14 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL143
72288-650-74basic care mucus er max14 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL143
72288-650-74basic care mucus er max1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-650BASIC CARE MUCUS ER MAX (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 4 package rows20220507_9ab3d192-0fd4-48fd-95ea-3182c63a7327.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN9ab3d192-0fd4-48fd-95ea-3182c63a73273
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD9ab3d192-0fd4-48fd-95ea-3182c63a73273
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY9ab3d192-0fd4-48fd-95ea-3182c63a73273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-650-02722880650023 BLISTER PACK in 1 CARTON (72288-650-02) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2021-08-110000-00-00NoNoCurrent
72288-650-74722880650741 BLISTER PACK in 1 CARTON (72288-650-74) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-08-110000-00-00NoNoCurrent