FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan Hydrobromide HBR

Product NDC
11822-9996
11-digit product format
118229996
Labeler code
11822
Product ID
11822-9996_3b1ee432-8657-4ef6-9b89-cf0127157e64
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin and dextromethorphan hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RITE-AID
Application
ANDA214781
Marketing category
ANDA
Marketing start
2022-06-28
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 Hydrobromide 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
11822-9996-1Guaifenesin and Dextromethorphan Hydrobromide HBR14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE145
11822-9996-1Guaifenesin and Dextromethorphan Hydrobromide HBR1 in 1 CARTONTABLET, EXTENDED RELEASE15
11822-9996-2Guaifenesin and Dextromethorphan Hydrobromide HBR2 in 1 CARTONTABLET, EXTENDED RELEASE25
11822-9996-2Guaifenesin and Dextromethorphan Hydrobromide HBR14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-9996GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE HBR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RITE-AID]5Current NDC, Legacy NDC, 4 package rows20221208_2343f031-d658-498a-b5d1-6dcdb26b3cf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN2343f031-d658-498a-b5d1-6dcdb26b3cf05
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD2343f031-d658-498a-b5d1-6dcdb26b3cf05
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY2343f031-d658-498a-b5d1-6dcdb26b3cf05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-9996-1118229996011 BLISTER PACK in 1 CARTON (11822-9996-1) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-06-280000-00-00NoNoCurrent
11822-9996-2118229996022 BLISTER PACK in 1 CARTON (11822-9996-2) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2022-06-280000-00-00NoNoCurrent