FDA.reportPublic FDA data

Rugby Mucus Relief DM ER

Product NDC
0536-1446
11-digit product format
005361446
Labeler code
0536
Product ID
0536-1446_12e5b851-addc-4d89-8146-dbafd37f9d26
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA207602
Marketing category
ANDA
Marketing start
2025-04-02
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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05c2088c7a36db…
2026-10-15 13:18:302026-09A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05c2088c7a36db…
2026-09-14 22:38:342026-08A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-0584e616aacf4f…
2026-09-14 22:38:342026-08A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-0584e616aacf4f…
2026-08-18 06:07:402026-07A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
GUAIFENESIN600 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
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
f2629794-4845-4ca6-8668-a21a56f182cbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1446-34Rugby Mucus Relief DM ER20 in 1 BOTTLETABLET, EXTENDED RELEASE202
0536-1446-34Rugby Mucus Relief DM ER1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1446-34EA - Each0536-14469fd5f936-edc8-4b44-a543-46e428d01bc012025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1446RUGBY MUCUS RELIEF DM ER (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [RUGBY LABORATORIES]2Current NDC, 2 package rows20250406_f2629794-4845-4ca6-8668-a21a56f182cb.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD SENSE MUCUS DMDEXTROMETHORPHAN HBR, GUAIFENESINA-S Medication Solutions9995f480-da71-4e3b-8154-9eefaeb9299d2024-09-26WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLC96409b52-b0ec-444b-bc39-fd41070e98552024-04-07WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
equaline mucus dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINUnited Natural Foods, Inc. dba UNFI1db69578-2331-4fce-91a4-95c54cb7dc072023-08-07WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
Equaline Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINUnited Natural Foods, Inc. dba UNFI04334889-f75e-4a19-a8b4-47b8db18b9aa2023-08-02WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
DG health mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, LLCadd72ca5-94cd-437f-b30f-6149c08b5f212022-11-14WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
basic care mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINAmazon.com Services LLCac01ad52-483a-4cce-9279-51ceecada9b92021-07-13WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNf2629794-4845-4ca6-8668-a21a56f182cb2
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDf2629794-4845-4ca6-8668-a21a56f182cb2
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYf2629794-4845-4ca6-8668-a21a56f182cb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0536-1446-34005361446341 BOTTLE in 1 CARTON (0536-1446-34) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2025-04-02NoNoCurrent