FDA.reportPublic FDA data

CVS Severe Tussin CF Max

Product NDC
69842-947
11-digit product format
698420947
Labeler code
69842
Product ID
69842-947_fcd4d7c6-f6f2-45c9-b697-4272f40700d6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS PHARMACY
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-15
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
650; 20 mg/20mL; mg/20mL
Pharmacologic classes
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
CVS Severe Tussin CF Max
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 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
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1919076Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e32881f5-2bb5-4756-aa86-a09473ab590bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-02-23CVS Health ™ Maximum Strength Severe Tussin CF Max Drug Facts
2024-02-23CVS Health ™ Maximum Strength Severe Tussin CF Max Drug Facts
2024-01-30CVS Health ™ Maximum Strength Severe Tussin CF Max Drug Facts
2024-01-30CVS Health ™ Maximum Strength Severe Tussin CF Max Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-947-08CVS Severe Tussin CF Max237 mL in 1 BOTTLESOLUTION2376
69842-947-08CVS Severe Tussin CF Max1 in 1 CARTONSOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-947CVS SEVERE TUSSIN CF MAX (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) SOLUTION [CVS PHARMACY]5Current NDC, Legacy NDC, 2 package rows20240224_e32881f5-2bb5-4756-aa86-a09473ab590b.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 23 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Congestion Relief Cooling Nasal MistOXYMETAZOLINE HCLHaleon US Holdings LLC90125a19-eed7-4ca4-a6dc-f38026c74d542026-06-08WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company54254b61-7861-4eeb-bd3c-54fd5266f4a72026-06-08WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINMajor Pharmaceuticalsaa662428-e61f-4e22-af4d-8cf63df68c992026-06-08WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, GUAIFENESIN AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLTARGET CORPORATION47a218a0-6395-36bd-e063-6394a90a265a2026-06-05WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCLTARGET CORPORATION4779288a-9850-8490-e063-6394a90abe512026-06-05WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCLReckitt Benckiser LLC4df37cfb-299f-661f-e063-6394a90ab3372026-06-04WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEBayer HealthCare LLC.53715ea4-42b3-5887-e063-6294a90a42492026-06-04WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association, Inc.b0d38db9-22a9-4dd8-8e0f-dd81805e724b2026-06-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY65d4d7ea-c080-404e-9836-7d6bdcc5ea7d2026-06-04WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfe9d6a6e-38a1-44ae-a30f-596c5ec7d0572026-06-03WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyb0c1d635-0f85-433a-b479-51c68d259faa2026-06-03WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWalgreen Companyde4e8af4-d3d0-44b3-aea3-79016803ccdc2026-06-03WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR AND GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICEdc0a3761-bbe2-4261-a183-594f5fb12b0b2026-06-03WarningsExact identifier
application number: M012
Cold and Flu Daytime, NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALMART INC.f278cc81-65b2-4e45-be5b-41152cbb67c42026-06-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamily Dollar Services Inc358ba91d-06a4-49c9-994d-4e4bf9499dcd2026-06-03WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANCardinal Health 107, LLCc5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed2026-06-02WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5349dbde-730c-610f-e063-6394a90a952a2026-06-02WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATECardinal Health 107, LLCa9130f36-4761-4e6b-a383-eca3db06ea932026-06-02WarningsExact identifier
application number: M012
Topcare Day Time Nite Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCaed387e0-5a8b-4caf-a373-3e04496a49832026-06-02WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.53371691-2510-5039-e063-6394a90a6ea92026-06-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1919076acetaminophen 325 MG / dextromethorphan HBr 10 MG in 10 mL Oral SolutionPSNe32881f5-2bb5-4756-aa86-a09473ab590b6
1919076acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCDe32881f5-2bb5-4756-aa86-a09473ab590b6
1919076acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral SolutionSYe32881f5-2bb5-4756-aa86-a09473ab590b6
1919076acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral SolutionSYe32881f5-2bb5-4756-aa86-a09473ab590b6
1919076APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSYe32881f5-2bb5-4756-aa86-a09473ab590b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-947-08698420947081 BOTTLE in 1 CARTON (69842-947-08) / 237 mL in 1 BOTTLE1 bottle2019-04-150000-00-00NoNoCurrent