FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBR

Product NDC
43598-232
Requested package NDC
43598-232-37
11-digit product format
435980232
Labeler code
43598
Product ID
43598-232_e2cca72b-3d64-2919-9631-c911b77a3b0f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBR
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA217340
Marketing category
ANDA
Marketing start
2023-08-15
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
A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01
A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-018072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-016a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-011c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-019b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-019b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin and Dextromethorphan HBR
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
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099074Internal RxNorm lookup
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
5e95d8c0-d521-45b6-ccaf-7786fbd14d5cAvailable 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
43598-232-37Guaifenesin and Dextromethorphan HBR3 in 1 CARTONTABLET, EXTENDED RELEASE32
43598-232-37Guaifenesin and Dextromethorphan HBR14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-232GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]1Current NDC, 2 package rows20240302_5e95d8c0-d521-45b6-ccaf-7786fbd14d5c.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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Members Mark Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRSAM'S WEST INC2b59f90b-b8fc-03c0-3527-a8efa97fbfe32025-11-30WarningsExact identifier
application applno (ANDA): 217340
application number: ANDA217340
Guaifenesin and Dextromethorphan HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRDr. Reddy's Laboratories Inc.5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2025-11-30WarningsExact identifier
application applno (ANDA): 217340
application number: ANDA217340
ndc (package): 43598-232-37
ndc (product): 43598-232
ndc11 (package): 43598023237
Guaifenesin and Dextromethorphan HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRCVS Pharmacy7942eeae-0528-4416-bd2f-b05acc71c0a92024-11-10WarningsExact identifier
application applno (ANDA): 217340
application number: ANDA217340
Guaifenesin and Dextromethorphan HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRDr. Reddy's Laboratories Inc.49d7f70d-ff79-0708-3eda-efa5bf61da6c2024-03-19WarningsExact identifier
application applno (ANDA): 217340
application number: ANDA217340

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-232-37435980232373 BLISTER PACK in 1 CARTON (43598-232-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2023-12-01NoNoCurrent