FDA.reportPublic FDA data

Cough and Chest Congestion Maximum Strength

Product NDC
69676-0077
11-digit product format
696760077
Labeler code
69676
Product ID
69676-0077_3857582e-3b04-90e9-e063-6294a90ab3d9
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Genexa Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-12
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
400; 20 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 Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e920b700-30d3-3266-e053-2a95a90a0639Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
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a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0077-92024-02-12C16284748780-11030e365-408c-111a-e063-dadaa90a10e2Cough and Chest Congestion Maximum Strength
69676-0077-92024-01-30C16284748780-11030e365-408c-111a-e063-dadaa90a10e2Cough and Chest Congestion Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0077-9Cough and Chest Congestion Maximum Strength177 mL in 1 BOTTLE, PLASTICSUSPENSION1777
69676-0077-9Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack177 mL in 1 BOTTLE, PLASTICSUSPENSION177 mL400 mg in 20mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0077COUGH AND CHEST CONGESTION MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN) SUSPENSION [GENEXA INC.]6Current NDC, Legacy NDC, 1 package rows20250212_e920b700-30d3-3266-e053-2a95a90a0639.zip
69676-0077MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE) KIT [GENEXA INC.]1Current NDC, Legacy NDC20240905_18835205-a9e3-15c2-e063-6394a90a8107.zip

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 88 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation1affbef6-dd27-40c2-a5d3-b121aa62496a2025-11-15WarningsExact identifier
application number: M012
Cold and Flu Day, NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Companyb9adfb5d-6576-4ff8-a7d7-a89b867c52922025-11-14WarningsExact identifier
application number: M012
PECGEN DMXDEXTROMETHORPHAN HBR, GUAIFENESINKRAMER NOVISa627824c-5e3d-4672-a047-6c801b50b4322025-11-14WarningsExact identifier
application number: M012
Supress DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINKRAMER NOVIS7da0611e-729c-4cf8-88f3-f8877b9f5cfa2025-11-14WarningsExact identifier
application number: M012
G-ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Novisc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc2025-11-14WarningsExact identifier
application number: M012
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb2c0692c-ed0b-4fcf-b88d-59a788b124c62025-11-14WarningsExact identifier
application number: M012
Guaifenesin 400mgGUAIFENESINMarlex Pharmaceuticals Inc13f4db4e-687e-9d7b-e063-6294a90ab0882025-11-13WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINMarlex Pharmaceuticals Inc13b8f480-d1ac-d70c-e063-6394a90ab4f42025-11-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLPD-Rx Pharmaceuticals, Inc.c1873a4c-661f-4896-bcc0-f6d3a655de942025-11-13WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLCc24b9489-208c-472b-8ae5-c6e86c12e04d2025-11-13WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Chest Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLC8c821671-dc68-4e27-aa87-b4e45ade98172025-11-13WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Cough Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC6a6f5da8-6433-4284-8df7-2d5b099b74dc2025-11-13WarningsExact identifier
application number: M012
equaline allergyDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI8e4eb1eb-5b55-4531-94d2-998425ec80ed2025-11-13WarningsExact identifier
application number: M012
Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.7a78f24b-7c23-4318-99dc-90c05db185b12025-11-13WarningsExact identifier
application number: M012
ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Noviscffd6d5f-0cb2-4d38-bdb0-6a21120418cc2025-11-13WarningsExact identifier
application number: M012
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb6da1659-8c79-4cce-a817-907a7f061a2d2025-11-13WarningsExact identifier
application number: M012
Tussi PresGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novis0d4ee530-2a5c-41a0-88bf-ac92d538661b2025-11-12WarningsExact identifier
application number: M012
4 Way Fast ActingPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa8fc41c7-4425-41b8-b1c6-eb22ac0547342025-11-12WarningsExact identifier
application number: M012
Quality Choice Vapor SteamCAMPHOR (SYNTHETIC)Chain Drug Marketing Association, Inc.1f1e6be5-d407-330c-e063-6294a90a4e802025-11-12WarningsExact identifier
application number: M012
G-Supress DXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5dd44337-f3aa-4e73-a206-4a29850a2f7c2025-11-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2692304{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Suspension) } PackGPCK18835205-a9e3-15c2-e063-6394a90a81072
26923041 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Suspension) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Suspension) PackPSN18835205-a9e3-15c2-e063-6394a90a81072
2692302acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SuspensionPSN18835205-a9e3-15c2-e063-6394a90a81072
2692303dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SuspensionPSN18835205-a9e3-15c2-e063-6394a90a81072
2692302acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SuspensionSCD18835205-a9e3-15c2-e063-6394a90a81072
2692303dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SuspensionSCD18835205-a9e3-15c2-e063-6394a90a81072
26923041 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Suspension) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Suspension) PackSY18835205-a9e3-15c2-e063-6394a90a81072
2692302acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SuspensionSY18835205-a9e3-15c2-e063-6394a90a81072
2692302APAP 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SuspensionSY18835205-a9e3-15c2-e063-6394a90a81072
2692303dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SuspensionSY18835205-a9e3-15c2-e063-6394a90a81072
2692303dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SuspensionSY18835205-a9e3-15c2-e063-6394a90a81072

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69676-0077-969676007709177 mL in 1 BOTTLE, PLASTIC (69676-0077-9) 177 ml2024-02-120000-00-00NoNoCurrent