equaline mucus dm

Product NDC
41163-599
11-digit product format
411630599
Labeler code
41163
Product ID
41163-599_4fc293f4-69f6-4050-a780-bed58bb68671
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA207602
Marketing category
ANDA
Marketing start
2020-02-18
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 600 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
equaline mucus dm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1298324

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
41163-599-01equaline mucus dm1 in 1 CARTONTABLET, EXTENDED RELEASE13
41163-599-01equaline mucus dm20 in 1 BOTTLETABLET, EXTENDED RELEASE203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-599EQUALINE MUCUS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI]3Current NDC, Legacy NDC, 2 package rows20230808_1db69578-2331-4fce-91a4-95c54cb7dc07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN1db69578-2331-4fce-91a4-95c54cb7dc073
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD1db69578-2331-4fce-91a4-95c54cb7dc073
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY1db69578-2331-4fce-91a4-95c54cb7dc073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-599-01411630599011 BOTTLE in 1 CARTON (41163-599-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-02-180000-00-00NoNoCurrent