DG health mucus dm

Product NDC
55910-575
11-digit product format
559100575
Labeler code
55910
Product ID
55910-575_2a65e578-eefd-4d1e-ad97-08939a044ebe
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dolgencorp, LLC
Application
ANDA207602
Marketing category
ANDA
Marketing start
2018-07-02
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
60; 1200 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
A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05
A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05

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 UTC2026-02A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
DG health mucus dm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN60 mg/1
DEXTROMETHORPHAN HYDROBROMIDE1200 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
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
add72ca5-94cd-437f-b30f-6149c08b5f21Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-575-03DG health mucus dm7 in 1 CARTONTABLET, EXTENDED RELEASE73
55910-575-03DG health mucus dm1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE13
55910-575-66DG health mucus dm1 in 1 CARTONTABLET, EXTENDED RELEASE13
55910-575-66DG health mucus dm14 in 1 BOTTLETABLET, EXTENDED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-575DG HEALTH MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [DOLGENCORP, LLC]3Current NDC, Legacy NDC, 4 package rows20221130_add72ca5-94cd-437f-b30f-6149c08b5f21.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 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RUGBY MUCUS RELIEF DM ERDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories8090d561-0478-435d-ad6f-2334e1823bc32026-07-28WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
Good Sense Mucus DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Company34f26b33-af34-470a-b57e-921fbdcbd9af2026-07-13WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
MUCUS RELIEF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdb57f6b3-30ca-4a65-9043-f61be24d9b502026-06-25WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
mucus relief DM MAXDEXTROMETHORPHAN HBR, GUAIFENESINRite Aid Corporationa5fd7378-fd7b-400b-a374-0f3bee37702d2026-06-03WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
mucus relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation84b5d83d-aea5-42ed-b20c-96d3b389c8c02026-05-27WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
mucus dm extended releaseGUAIFENESIN, DEXTROMETHORPHAN HBRCVS Pharmacy1bc37ee4-df27-4358-b724-6b55406dbce62026-05-08WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINHyVee Inc6bce66d6-e76a-4273-aff9-7ee6adc189802026-03-18WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
MUCUS DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHyVee Inc4ffa61d9-d24d-4982-a318-1660b56704e62026-03-02WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
Good Sense Mucus DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSportpharm LLC81fb0ce7-1b13-4b9d-8f98-671ffd9205c32026-02-23WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
MUCUS RELIEF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e12026-02-17WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
RUGBY MUCUS RELIEF DM ERDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINA-S Medication Solutions511a5d9b-16a6-481c-a3d3-bcba911ecc9d2026-02-11WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
Berkley and Jensen Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINBJWCd3b94cce-e6f3-43ec-a927-7b71837444332025-12-17WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINMeijer Distribution Inccb2b9828-1665-4b66-a59a-b9f9539b51b52025-09-17WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
GOOD NEIGHBOR PHARMACY MUCUS DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergenf0aea945-1c18-4c6f-a7d1-6d56624011bb2025-09-12WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
good neighbor pharmacy mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINAmerisource Bergenf7925a6b-7029-4389-bf1b-8c0f5e79b9502025-09-11WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
kirkland signature mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINCostco Wholesale Companyd2151492-c6bb-42c7-887f-37ef3eab34602025-08-20WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
good sense mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINL Perrigo Company654dc991-1984-43cc-a00e-0c85d910b3232025-08-20WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
mucus dm extended releaseGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDECVS Pharmacy6c9540ae-aea1-4717-8dca-60850ebdb1b42025-08-04WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
Topcare Mucus DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINTopco Associates LLCc12c68c3-c1bf-45dd-a311-fe1005189ec12025-07-16WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
Exchange Select Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINArmy & Air Force Exchange Service99a11bea-8cf5-4c5d-95b1-eaedccaf9e7d2025-07-03WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNadd72ca5-94cd-437f-b30f-6149c08b5f213
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDadd72ca5-94cd-437f-b30f-6149c08b5f213
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYadd72ca5-94cd-437f-b30f-6149c08b5f213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-575-03559100575037 BLISTER PACK in 1 CARTON (55910-575-03) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK7 blister pack2022-11-030000-00-00NoNoCurrent
55910-575-66559100575661 BOTTLE in 1 CARTON (55910-575-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-07-020000-00-00NoNoCurrent