FDA.reportPublic FDA data

Betr chest congestion relief

Product NDC
80267-002
11-digit product format
802670002
Labeler code
80267
Product ID
80267-002_5855b61a-c880-47b0-a67e-4e6cecb47f2c
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Live Betr LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2021-09-30
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
Betr chest congestion relief
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
80267-002-74Betr chest congestion relief14 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL142
80267-002-74Betr chest congestion relief1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80267-002BETR CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [LIVE BETR LLC]2Current NDC, Legacy NDC, 2 package rows20230223_add40484-8e77-464b-939c-a3c620b993cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNadd40484-8e77-464b-939c-a3c620b993cb2
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDadd40484-8e77-464b-939c-a3c620b993cb2
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYadd40484-8e77-464b-939c-a3c620b993cb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80267-002-74802670002741 BLISTER PACK in 1 CARTON (80267-002-74) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-09-300000-00-00NoNoCurrent