FDA.reportPublic FDA data

Guaifenesin D

Product NDC
70000-0580
11-digit product format
700000580
Labeler code
70000
Product ID
70000-0580_7c1294bf-52e9-4e14-afdf-220a15503883
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
ANDA212542
Marketing category
ANDA
Marketing start
2021-05-06
Marketing end
0000-00-00
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
600 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70000-0580DDiscontinued by firm2026-08-03
excluded packagepackage70000-058070000-0580-1DDiscontinued by firm2026-08-03
excluded packagepackage70000-058070000-0580-2DDiscontinued by firm2026-08-03

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
A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-28
A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-28

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212542-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-04-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212542-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-04-2887673890dc5c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0580-1EA - Each70000-0580bb79412e-ee82-4697-8c8e-52592c81b23312022-06-06
70000-0580-2EA - Each70000-0580d63d5415-86e8-4d05-bd8a-0fca2491d23212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0580GUAIFENESIN D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]5Legacy NDC20220604_3c40c30b-a7e1-470d-845a-a3d93bed9491.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDERUGBY LABORATORIES, INC.997946e6-eff0-4c15-8694-020a19c2d3362026-05-06WarningsExact identifier
application applno (ANDA): 212542
application number: ANDA212542
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLStrategic Sourcing Services LLC27f85134-cd38-b33c-e063-6394a90a05a82024-11-28WarningsExact identifier
application applno (ANDA): 212542
application number: ANDA212542
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLOhm Laboratories, Inc.2521ecd3-28f3-a13c-e063-6394a90a72452024-10-23WarningsExact identifier
application applno (ANDA): 212542
application number: ANDA212542
MAXIMUM STRENGTH Mucus DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy9a560b80-972c-4af5-8fe8-eaef0b0d83b32022-12-01WarningsExact identifier
application applno (ANDA): 212542
application number: ANDA212542
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Companyabecb791-b635-482f-bb99-3ee4b7093e782022-06-24WarningsExact identifier
application applno (ANDA): 212542
application number: ANDA212542
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy, Inc.4dee850b-b170-4ef9-ae02-3db9bfa05abe2022-06-08WarningsExact identifier
application applno (ANDA): 212542
application number: ANDA212542
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCc857bcd9-6696-40d5-93c0-65097598cd4b2022-04-08WarningsExact identifier
application applno (ANDA): 212542
application number: ANDA212542
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCd139fd8d-66fd-4484-8e78-ed90c505d9992022-02-08WarningsExact identifier
application applno (ANDA): 212542
application number: ANDA212542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0580-1700000580011 BLISTER PACK in 1 CARTON (70000-0580-1) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-05-060000-00-00NoNoCurrent
70000-0580-2700000580022 BLISTER PACK in 1 CARTON (70000-0580-2) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2021-05-060000-00-00NoNoCurrent