FDA.reportPublic FDA data

MUCUS RELIEF - DM MAXIMUM STRENGTH

Product NDC
73581-406
Requested package NDC
73581-406-05
11-digit product format
735810406
Labeler code
73581
Product ID
73581-406_5506d60e-e6c0-96fe-e063-6394a90aa87a
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
YYBA CORP
Application
ANDA206941
Marketing category
ANDA
Marketing start
2026-06-16
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
60 mg/1; 1200 mg/1
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]
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17
A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17a50c72e98297…
2026-08-01 22:54:322026-06A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEF - DM MAXIMUM STRENGTHGUAIFENESIN, DEXTROMETHORPHAN HBRYYBA CORP4f6da14e-f2ca-cb33-e063-6394a90a9ff82026-06-24WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
ndc (package): 73581-406-05
ndc (product): 73581-406
ndc11 (package): 73581040605
GUAIFENESIN AND DEXTROMETHORPHAN HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRTOPCO ASSOCIATES LLC3a9737c0-e413-dfd1-e063-6294a90aaebd2026-04-23WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRVESPYR BRANDS LLC1c8fbf40-17c1-4ee9-a2b9-ca4a08e082932026-04-13WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRSportpharm LLC2f170b35-03a8-4d2e-a4ea-21cccf693d9e2026-02-18WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRSportpharm LLC3b5c5617-8499-7fc8-e063-6394a90aa86c2026-02-06WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLC88bc399a-2b71-45a7-bdfb-226ff1df05362026-01-30WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLCd0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b72025-11-13WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRTarget Corporation15434143-ab8e-4cf9-e063-6394a90a23882025-10-30WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
AMAZON BASIC CARE MUCUS DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAmazon.com Services LLC10eda178-a9cf-685c-e063-6294a90ae5ec2025-09-25WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Maximum Strength Mucus DM Extended ReleaseGUAIFENESIN AND DEXTROMETHORPHAN HBRCVS Pharmacy, Inc.5ea560d1-6443-4271-842c-7801fc6a60432025-08-11WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Mucus DM Extended ReleaseGUAIFENESIN AND DEXTROMETHORPHAN HBRCVS Pharmacy, Inc.2aa1889f-bb76-4e70-81b5-c25c4ebab1132025-08-11WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
MUCUS RELIEF DMGUAIFENESIN AND DEXTROMETHORPHAN HBRBetter Living Brands LLCdca1d482-062f-4915-b0a7-c00ab47aaff82025-07-25WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Mucus Relief DM MAXIMUM STRENGTHGUAIFENESIN AND DEXTROMETHORPHAN HBRBetter Living Brands LLC4ee69f46-3dc6-4249-9b04-186fa0a13e842025-07-25WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
COUGH AND CONGESTION EXTENDED RELEASEGUAIFENESIN AND DEXTROMETHORPHAN HBRCVS Pharmacy, Inc.14254a0c-a843-6eec-e063-6394a90a72c52025-07-16WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRKROGER COMPANY15e54152-dc82-6442-e063-6294a90a85412025-07-16WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRKROGER COMPANY15b98b7d-2274-450d-e063-6394a90a8d1d2025-07-16WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASEGUAIFENESIN AND DEXTROMETHORPHAN HBRCVS Pharmacy, Inc.13ee8bb1-9525-a5bc-e063-6294a90a9db92025-07-16WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
MUCUS RELIEF DMGUAIFENESIN AND DEXTROMETHORPHAN HBRHarris Teeter17eee39b-5a7a-ba20-e063-6294a90ac3922025-04-29WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRHarris Teeter826d9c3c-7535-48bb-906e-d75e2ec670db2025-04-29WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLC02d2a5a6-36bb-45b5-aba7-779615b276ed2025-04-05WarningsExact identifier
application applno (ANDA): 206941
application number: ANDA206941

Additional Listing Data#

Finished product
Yes
Brand name base
MUCUS RELIEF - DM
Brand name suffix
MAXIMUM STRENGTH
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE60 mg/1
GUAIFENESIN1200 mg/1

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
1099074Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f6da14e-f2ca-cb33-e063-6394a90a9ff8Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
73581-406-057358104060550 TABLET in 1 BOTTLE (73581-406-05)50 tablet2026-06-160Current