FDA.reportPublic FDA data

kirkland signature mucus dm

Product NDC
63981-812
11-digit product format
639810812
Labeler code
63981
Product ID
63981-812_10b26050-9454-4405-a5d2-b74b8f29f15e
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA207602
Marketing category
ANDA
Marketing start
2023-05-19
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 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-0587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-055aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-058869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-053f01610625f2…
2019-12-14 00:12 UTC2019-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-053f01610625f2…
2019-09-15 20:21 UTC2019-09A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05b00525d2431f…
2019-09-15 20:21 UTC2019-09A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05ea99ee380514…
2019-07-19 19:46 UTC2019-07A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-056a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-051c564ffb4f44…
2024-02-18 07:12 UTC2024-02A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05a72a2bbeb626…

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 · 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
ndc (product): 63981-812
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

Additional Listing Data#

Finished product
Yes
Brand name base
kirkland signature mucus dm
Listing expiration
2026-12-31

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
d2151492-c6bb-42c7-887f-37ef3eab3460Available 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
63981-812-01kirkland signature mucus dm1 in 1 CARTONTABLET, EXTENDED RELEASE14
63981-812-01kirkland signature mucus dm84 in 1 BOTTLETABLET, EXTENDED RELEASE844

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-812-01EA - Each63981-812a675fb05-a7aa-4dd2-94cb-1481c98f535412023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-812KIRKLAND SIGNATURE MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [COSTCO WHOLESALE COMPANY]3Current NDC, 2 package rows20250322_d2151492-c6bb-42c7-887f-37ef3eab3460.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNd2151492-c6bb-42c7-887f-37ef3eab34604
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDd2151492-c6bb-42c7-887f-37ef3eab34604
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYd2151492-c6bb-42c7-887f-37ef3eab34604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63981-812-01639810812011 BOTTLE in 1 CARTON (63981-812-01) / 84 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2023-05-19NoNoCurrent