Mucus Relief DM

Product NDC
59726-733
11-digit product format
597260733
Labeler code
59726
Product ID
59726-733_25a81a18-9757-4dcf-89d7-6413afb909e4
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA209692
Marketing category
ANDA
Marketing start
2018-12-31
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
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
A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01
A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01

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 UTC2026-02A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01782e0a99824c…
2021-12-28 21:50 UTC2021-12A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM
Listing expiration
2027-12-31

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
a397799d-46a6-447b-9498-17436d218e29Available 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-12-05Drug Facts
2020-09-27Drug Facts
2020-09-25Drug Facts
2020-07-22Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-733-06Mucus Relief DM1 in 1 BLISTER PACKTABLET15
59726-733-06Mucus Relief DM6 in 1 CARTONTABLET65
59726-733-20Mucus Relief DM1 in 1 BLISTER PACKTABLET15
59726-733-20Mucus Relief DM20 in 1 CARTONTABLET205
59726-733-40Mucus Relief DM1 in 1 BLISTER PACKTABLET15
59726-733-40Mucus Relief DM40 in 1 CARTONTABLET405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-733MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [P & L DEVELOPMENT, LLC]4Current NDC, Legacy NDC, 6 package rows20220217_a397799d-46a6-447b-9498-17436d218e29.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 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBREQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)3850544d-0d25-429e-98a9-5c4ad6cfd2222026-07-14WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)6d454e89-59ce-40dc-b0d2-3330a7df519f2026-04-15WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)344de7bb-de3b-4c15-a920-72d94e5e0e9f2026-03-18WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRCVS Pharmacy59c338a0-8dc9-43a7-b8df-c26ae475def32026-03-18WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRCARDINAL HEALTH 110, LLC. DBA LEADER 70000e24fd894-5dee-4f46-aafa-fbf9f0b166fd2026-02-10WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Maximum Strength Guaifenesin DMGUAIFENESIN, DEXTROMETHORPHAN HBRRugby Laboratories2c9515f8-3120-4dbb-a7fc-d89fc57271482026-02-10WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRRugby Laboratories69cd399a-0103-4543-bb06-c7cccffe9cc42026-02-10WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRP & L Development, LLCa397799d-46a6-447b-9498-17436d218e292026-01-28WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
ndc (product): 59726-733
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2426bf76-19bf-4bfd-8f9e-3b348e4b56412025-11-11WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRFamily Dollar (FAMILY WELLNESS)ebc1a915-f643-4878-9d7a-67a9c6a26b202025-10-30WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRFamily Dollar (FAMILY WELLNESS)b60d1cc6-086c-4483-a101-c5f8d60009692025-10-29WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRWalgreensbe5ab61a-abd6-4dee-9607-2f1e2c47b2dc2025-08-28WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DM Extended Release Caplets Maximum StrengthGUAIFENESIN, DEXTROMETHORPHAN HBRWalgreens11310cf8-ea34-47a2-b4d7-fe1131fef4622025-08-28WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DM Maximum StrengthGUAIFENESIN, DEXTROMETHORPHAN HBRRite Aid Corporation8467474f-6278-47d9-8228-451d08ddf9832025-08-20WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRRite Aid Corporation035693ed-d720-430b-98f5-fe4b5dec5db62025-08-20WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DM Maximum StrengthGUAIFENESIN, DEXTROMETHORPHAN HBRChain Drug Consortium, LLCd6aae1a1-0ab9-4b26-9f62-b8761014bb352025-06-30WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRATLANTIC BIOLOGICALS CORP.308f50dd-e8d6-0264-e063-6394a90afa682025-06-27WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAmneal Pharmaceuticals LLC5760a828-1c28-4272-a7b7-ac98466aa2942024-10-25WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAmneal Pharmaceuticals LLCcfdbcdb0-531a-4d95-ac5d-64d6d034b2522024-10-25WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRH E B20df2ffe-5281-4cd6-adb3-3a3d28788ef62024-08-02WarningsExact identifier
application applno (ANDA): 209692
application number: ANDA209692

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNa397799d-46a6-447b-9498-17436d218e295
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDa397799d-46a6-447b-9498-17436d218e295
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYa397799d-46a6-447b-9498-17436d218e295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-733-06597260733066 BLISTER PACK in 1 CARTON (59726-733-06) / 1 TABLET in 1 BLISTER PACK6 blister pack2018-12-310000-00-00NoNoCurrent
59726-733-205972607332020 BLISTER PACK in 1 CARTON (59726-733-20) / 1 TABLET in 1 BLISTER PACK20 blister pack2018-12-31NoNoCurrent
59726-733-405972607334040 BLISTER PACK in 1 CARTON (59726-733-40) / 1 TABLET in 1 BLISTER PACK40 blister pack2018-12-310000-00-00NoNoCurrent