FDA.reportPublic FDA data

Mucus Relief Cough

Product NDC
37808-594
11-digit product format
378080594
Labeler code
37808
Product ID
37808-594_383791ea-45e0-49d5-8085-b3b34ac03db9
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifensin
Dosage form
LIQUID
Route
ORAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5; 100 mg/5mL; mg/5mL
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
Mucus Relief Cough
Brand name suffix
Childrens
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1020138

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-594-04Mucus Relief CoughChildrens1 in 1 BOXLIQUID17
37808-594-04Mucus Relief CoughChildrens118 mL in 1 BOTTLE, PLASTICLIQUID1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-594MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HBR, GUAIFENSIN) LIQUID [H E B]7Current NDC, Legacy NDC, 2 package rows20240410_9ba5ca1b-2e3c-439e-8887-c26f144b88ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN9ba5ca1b-2e3c-439e-8887-c26f144b88ef7
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD9ba5ca1b-2e3c-439e-8887-c26f144b88ef7
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY9ba5ca1b-2e3c-439e-8887-c26f144b88ef7
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY9ba5ca1b-2e3c-439e-8887-c26f144b88ef7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-594-04378080594041 BOTTLE, PLASTIC in 1 BOX (37808-594-04) / 118 mL in 1 BOTTLE, PLASTIC2016-07-310000-00-00NoNoCurrent