FDA.reportPublic FDA data

basic care mucus dm

Product NDC
72288-812
11-digit product format
722880812
Labeler code
72288
Product ID
72288-812_ac01ad52-483a-4cce-9279-51ceecada9b9
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA207602
Marketing category
ANDA
Marketing start
2021-07-09
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
60; 1200 mg/1; mg/1
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 dm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE60 mg/1
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1099074

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
72288-812-55basic care mucus dm1 in 1 CARTONTABLET, EXTENDED RELEASE11
72288-812-55basic care mucus dm42 in 1 BOTTLETABLET, EXTENDED RELEASE421
72288-812-66basic care mucus dm1 in 1 CARTONTABLET, EXTENDED RELEASE11
72288-812-66basic care mucus dm14 in 1 BOTTLETABLET, EXTENDED RELEASE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-812BASIC CARE MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [AMAZON.COM SERVICES LLC]1Current NDC, Legacy NDC, 4 package rows20210727_ac01ad52-483a-4cce-9279-51ceecada9b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNac01ad52-483a-4cce-9279-51ceecada9b91
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDac01ad52-483a-4cce-9279-51ceecada9b91
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYac01ad52-483a-4cce-9279-51ceecada9b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-812-55722880812551 BOTTLE in 1 CARTON (72288-812-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-07-130000-00-00NoNoCurrent
72288-812-66722880812661 BOTTLE in 1 CARTON (72288-812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-07-090000-00-00NoNoCurrent