Revasol Tussin

Product NDC
84379-313
11-digit product format
843790313
Labeler code
84379
Product ID
84379-313_4b84bd2e-c45a-9c59-e063-6294a90ad1e5
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Rnv LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-19
Substance
GUAIFENESIN
Active strength
200 mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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
Revasol Tussin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1606850Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f66dc593-9023-40e8-9cc3-0380b04b4305Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84379-313-04Revasol Tussin118 mL in 1 BOTTLELIQUID1184
84379-313-16Revasol Tussin474 mL in 1 BOTTLELIQUID4744

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84379-313REVASOL TUSSIN (GUAIFENESIN) LIQUID [RNV LLC]2Current NDC, 2 package rows20240905_f66dc593-9023-40e8-9cc3-0380b04b4305.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 82 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion PowermaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.a6a2dd4a-a3c8-2dfa-e053-2995a90ada862025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Sparkling Original PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.bd49121c-7cba-c51f-e053-2995a90a921e2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare, LLC.a6b8dc25-0fb9-1823-e053-2a95a90adf932025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.c2232241-6e57-1427-e053-2995a90a488a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max GelsACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51dec468-fbb2-3489-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.d7711cd6-5058-548d-e053-2a95a90ac54d2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.a2f0285b-8550-fd26-e053-2995a90ab6152025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.f6c73f61-f4fc-377f-e053-6294a90a37972025-12-04WarningsExact identifier
application number: M012
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast FizzDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINBayer Healthcare LLC.a32e2a5e-9aa0-4e7c-e053-2995a90a31902025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.e2877488-3539-cba2-e053-2995a90a60052025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cough and Sore Throat FizzyChewsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.14951faa-9476-6f29-e063-6394a90a14c72025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid GelsALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTIONBayer HealthCare LLC.0c120569-622d-3a23-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and Flu FizzyChewsCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.149330be-24bd-b4a4-e063-6394a90a90072025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESINBayer HealthCare LLC.5278a128-41ec-4494-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Orange ZestASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.53188c41-3f13-311b-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.75894849-a0ba-57be-e053-2a91aa0a049a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Sparkling OriginalASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.531ab703-179a-70ad-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.7588ea67-68a9-4dc0-e053-2991aa0aa4712025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and CoughASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.75862805-2cfe-fb45-e053-2991aa0a14032025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5172dc01-4e7f-3307-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1606850guaiFENesin 200 MG in 10 mL Oral SuspensionPSNf66dc593-9023-40e8-9cc3-0380b04b43054
1606850guaifenesin 20 MG/ML Oral SuspensionSCDf66dc593-9023-40e8-9cc3-0380b04b43054
1606850guaifenesin 200 MG per 10 ML Oral SuspensionSYf66dc593-9023-40e8-9cc3-0380b04b43054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84379-313-0484379031304118 mL in 1 BOTTLE (84379-313-04) 118 ml2024-08-19NoNoCurrent
84379-313-1684379031316474 mL in 1 BOTTLE (84379-313-16) 474 ml2025-09-01NoNoCurrent