FDA.reportPublic FDA data

Guaifenesin and Pseudoephedrine HCl

Product NDC
0363-0134
11-digit product format
003630134
Labeler code
0363
Product ID
0363-0134_a8d412ac-63da-463b-a670-4d4c927b9782
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA213203
Marketing category
ANDA
Marketing start
2020-08-05
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
1200; 120 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
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
A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25
A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25

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 UTC2026-02A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-254b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-2587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-2587673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin and Pseudoephedrine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 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
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1244675Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c3b99f0-83af-4df0-a681-f2fc8778f8bbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0134-782024-01-30C16284748780-11030e365-20e7-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0134-78Guaifenesin and Pseudoephedrine HCl2 in 1 CARTONTABLET, EXTENDED RELEASE27
0363-0134-78Guaifenesin and Pseudoephedrine HCl12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0134GUAIFENESIN AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [WALGREEN CO.]7Current NDC, Legacy NDC, 2 package rows20240423_4c3b99f0-83af-4df0-a681-f2fc8778f8bb.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLAmerisource Bergen775000bc-56de-4c72-87da-65bb33f063b32024-12-03WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLAurohealth LLC2f622f57-4de0-44a9-a21f-c98260574f1e2024-09-03WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLAurohealth LLC644dae51-7865-408c-a603-5eddffb90e532024-09-03WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLWALGREEN CO.4c3b99f0-83af-4df0-a681-f2fc8778f8bb2024-04-20WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
ndc (product): 0363-0134
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLMeijerc051be4b-88c9-e56f-e053-2995a90a3aa82023-12-01WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLKROGER COMPANYb97aeb2c-07ac-d00e-e053-2a95a90abf402023-12-01WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLWALGREEN CO.cc1ac1b4-cbc4-539c-e053-2a95a90a5b752023-12-01WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244675guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN4c3b99f0-83af-4df0-a681-f2fc8778f8bb7
124467512 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD4c3b99f0-83af-4df0-a681-f2fc8778f8bb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0134-78003630134782 BLISTER PACK in 1 CARTON (0363-0134-78) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2020-08-050000-00-00NoNoCurrent