FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBr

Product NDC
58602-824
11-digit product format
586020824
Labeler code
58602
Product ID
58602-824_3ff696ea-da6c-4fc6-8cff-9681519ed78d
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA206941
Marketing category
ANDA
Marketing start
2017-03-17
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 600 mg/1; 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]
NDC exclude flag
No
Listing certified through
2026-12-31
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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17782e0a99824c…
2021-12-28 21:50 UTC2021-12A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin and Dextromethorphan HBr
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN30 mg/1
DEXTROMETHORPHAN HYDROBROMIDE600 mg/1

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1298324Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
029ee6fb-df76-4df6-b717-70005d5708daAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-824-08Guaifenesin and Dextromethorphan HBr4 in 1 CARTONTABLET, EXTENDED RELEASE46
58602-824-08Guaifenesin and Dextromethorphan HBr10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE106
58602-824-67Guaifenesin and Dextromethorphan HBr10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE106
58602-824-67Guaifenesin and Dextromethorphan HBr2 in 1 CARTONTABLET, EXTENDED RELEASE26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-824GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [AUROHEALTH LLC]6Current NDC, Legacy NDC, 4 package rows20240210_029ee6fb-df76-4df6-b717-70005d5708da.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 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN029ee6fb-df76-4df6-b717-70005d5708da6
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD029ee6fb-df76-4df6-b717-70005d5708da6
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY029ee6fb-df76-4df6-b717-70005d5708da6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-824-08586020824084 BLISTER PACK in 1 CARTON (58602-824-08) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2017-03-170000-00-00NoNoCurrent
58602-824-67586020824672 BLISTER PACK in 1 CARTON (58602-824-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-03-170000-00-00NoNoCurrent