FDA.reportPublic FDA data

COUGH AND CHEST CONGESTION

Product NDC
51316-082
11-digit product format
513160082
Labeler code
51316
Product ID
51316-082_84b0c507-396e-48b0-8b1b-358e17c516c2
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-12
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 mg/20mL; mg/20mL
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
COUGH AND CHEST CONGESTION
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN200 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1790650Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dfe69c12-b5fe-46d1-a3bf-ef3729c2e786Available on FDA.report

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
51316-082-34COUGH AND CHEST CONGESTION1 in 1 CARTONSOLUTION12
51316-082-34COUGH AND CHEST CONGESTION237 mL in 1 BOTTLESOLUTION2372

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d22026-08-10WarningsExact identifier
application number: M012
TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa9f01760-e335-4410-a9b8-8edce28412702026-08-10WarningsExact identifier
application number: M012
GuaifedGUAIFENESINAldama Pharmaceuticals, Inc38f37272-2084-a33b-e063-6294a90ac1502026-08-10WarningsExact identifier
application number: M012
Chlorpheniramine MaleateCHLORPHENIRAMINE MALEATEPD-Rx Pharmaceuticals, Inc.7a3452a2-930f-48b1-8c59-dbceb10b9c782026-08-10WarningsExact identifier
application number: M012
Guaifed DMDEXTROMETHORPHAN, GUAIFENESINAldama Pharmaceuticals, Inc396bf716-0f61-9563-e063-6394a90a171b2026-08-10WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpeff114fe-fb15-48dd-b673-4d4d66406e692026-08-10WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)651b03a3-b85e-4028-a9f2-472bec16c8f42026-08-10WarningsExact identifier
application number: M012
NASALPHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC02a89765-2a75-470a-9fd6-8cce71dc19e92026-08-10WarningsExact identifier
application number: M012
WINCO Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWINCO FOODS, LLCf34bfb71-2c81-44d0-a2a0-4d320c43c2172026-08-07WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME ELDERBERRY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company11cac20e-9bb6-4e2d-8efd-4451f055c7b42026-08-07WarningsExact identifier
application number: M012
Winco Foods Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWINCO FOODS, LLC1d02b32a-e88d-4c70-b66d-7bdc22c25a432026-08-07WarningsExact identifier
application number: M012
foster and thrive daytime cold and flu relief nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCc1ecc56b-8052-4b0a-900a-dc93a24771bd2026-08-07WarningsExact identifier
application number: M012
Adult Long Lasting Cough ReliefDEXTROMETHORPHAN HBRShield Pharmaceuticals Corpbbf7d296-fa3d-43e5-984c-e9d2881a074d2026-08-07WarningsExact identifier
application number: M012
Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEWinCo Foods, LLC790d534a-0f40-495b-a815-67851ac3d20d2026-08-07WarningsExact identifier
application number: M012
Extra Moisturizing Nasal Pump Mist Anti DripOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLC46ebd262-c6a4-43ea-a7f6-506561bb3de42026-08-07WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINWINCO FOODS, LLCe6afa830-6ce2-4abc-b5c9-3f5f156444df2026-08-07WarningsExact identifier
application number: M012
Sinus PE Pressure plus Pain MAXIMUM STRENGTHACETAMINOPHEN, PHENYLEPHRINE HCLCVS Pharmacya3b073b4-494c-4531-b08e-475c86ba321d2026-08-07WarningsExact identifier
application number: M012
Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEWinCo Foods, LLCdc56197c-c108-4b35-b791-dde5c3384ddd2026-08-07WarningsExact identifier
application number: M012
Sinus Severe Non Drowsy, DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.84c30ec9-a7b5-4d2f-95b2-d6fb895945de2026-08-07WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC887cabe5-46d0-4f4e-8f5a-2cfdbc157b582026-08-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSNdfe69c12-b5fe-46d1-a3bf-ef3729c2e7862
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCDdfe69c12-b5fe-46d1-a3bf-ef3729c2e7862
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSYdfe69c12-b5fe-46d1-a3bf-ef3729c2e7862
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSYdfe69c12-b5fe-46d1-a3bf-ef3729c2e7862
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSYdfe69c12-b5fe-46d1-a3bf-ef3729c2e7862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-082-34513160082341 BOTTLE in 1 CARTON (51316-082-34) / 237 mL in 1 BOTTLE1 bottle2024-06-12NoNoCurrent