FDA.reportPublic FDA data

GUAIFENESIN AND DEXTROMETHORPHAN HBR

Product NDC
30142-963
11-digit product format
301420963
Labeler code
30142
Product ID
30142-963_68444eae-5f25-4a1c-bcde-a6bab50377af
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Kroger Company
Application
ANDA214781
Marketing category
ANDA
Marketing start
2022-05-23
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
60; 1200 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
GUAIFENESIN AND DEXTROMETHORPHAN HBR
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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-963-14GUAIFENESIN AND DEXTROMETHORPHAN HBR14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
30142-963-14GUAIFENESIN AND DEXTROMETHORPHAN HBR1 in 1 CARTONTABLET, EXTENDED RELEASE13
30142-963-28GUAIFENESIN AND DEXTROMETHORPHAN HBR14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
30142-963-28GUAIFENESIN AND DEXTROMETHORPHAN HBR2 in 1 CARTONTABLET, EXTENDED RELEASE23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-963GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [KROGER COMPANY]3Current NDC, Legacy NDC, 4 package rows20220526_8f7200ff-3e4d-414a-a1f9-fe8daac67cb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN8f7200ff-3e4d-414a-a1f9-fe8daac67cb13
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD8f7200ff-3e4d-414a-a1f9-fe8daac67cb13
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY8f7200ff-3e4d-414a-a1f9-fe8daac67cb13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-963-14301420963141 BLISTER PACK in 1 CARTON (30142-963-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-05-230000-00-00NoNoCurrent
30142-963-28301420963282 BLISTER PACK in 1 CARTON (30142-963-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2022-05-230000-00-00NoNoCurrent