FDA.reportPublic FDA data

Guaifenesin and Pseudoephedrine HCL

Product NDC
55111-798
11-digit product format
551110798
Labeler code
55111
Product ID
55111-798_9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine HCL
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddys Laboratories Limited
Application
ANDA208369
Marketing category
ANDA
Marketing start
2017-12-29
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
600; 60 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct55111-798UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage55111-79855111-798-77UNFINISHEDActive or certified unfinished drug listing2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage55111-798-77a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage55111-798-771d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage55111-798-77390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage55111-798-77e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage55111-798-77bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage55111-798-77f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage55111-798-77f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage55111-798-7768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage55111-798-7705c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage55111-798-7748b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage55111-798-7727f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage55111-798-778d62ce987f31…9fe9ef23e30d…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29
A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6V9V2RYJ8NInternal 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
1244675Internal RxNorm lookup
1305603Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
845a2dcc-9069-3141-ae13-f2063f36d130Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-798-09Guaifenesin and Pseudoephedrine HCL1 in 1 CARTONTABLET, EXTENDED RELEASE19
55111-798-09Guaifenesin and Pseudoephedrine HCL9 in 1 BLISTER PACKTABLET, EXTENDED RELEASE99
55111-798-18Guaifenesin and Pseudoephedrine HCL9 in 1 BLISTER PACKTABLET, EXTENDED RELEASE99
55111-798-18Guaifenesin and Pseudoephedrine HCL2 in 1 CARTONTABLET, EXTENDED RELEASE29
55111-798-35Guaifenesin and Pseudoephedrine HCL18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE189
55111-798-35Guaifenesin and Pseudoephedrine HCL1 in 1 CARTONTABLET, EXTENDED RELEASE19
55111-798-36Guaifenesin and Pseudoephedrine HCL4 in 1 CARTONTABLET, EXTENDED RELEASE49
55111-798-36Guaifenesin and Pseudoephedrine HCL9 in 1 BLISTER PACKTABLET, EXTENDED RELEASE99
55111-798-41Guaifenesin and Pseudoephedrine HCL2 in 1 CARTONTABLET, EXTENDED RELEASE29
55111-798-41Guaifenesin and Pseudoephedrine HCL18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE189

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-798-18EA - Each55111-798f7d9f617-7d04-4b25-8522-c35ca929981f12019-11-12
55111-798-35EA - Each55111-7980b995daa-2711-4eb0-a4fe-44607db168f812021-06-02
55111-798-36EA - Each55111-79802420e1e-a18c-4cdd-82b2-805700417e0412019-11-12
55111-798-41EA - Each55111-798ddc02983-a708-4457-9740-06b5ca67cce312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-798GUAIFENESIN AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]7Current NDC, Legacy NDC, 10 package rows20200312_845a2dcc-9069-3141-ae13-f2063f36d130.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLCVS Health Corp19cde6f8-649a-df69-7ee9-05da2cccba5b2025-12-10WarningsExact identifier
application applno (ANDA): 208369
application number: ANDA208369
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLRite Aid Corporation82654829-a2a5-06aa-930c-5bdd60e49b102025-12-10WarningsExact identifier
application applno (ANDA): 208369
application number: ANDA208369
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLWalgreens Company01047716-389b-df25-ebe6-c897fc47d3df2025-12-10WarningsExact identifier
application applno (ANDA): 208369
application number: ANDA208369
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLRite Aid Corporation9fb0c938-d24b-2371-95db-6c82d9511d722025-12-10WarningsExact identifier
application applno (ANDA): 208369
application number: ANDA208369
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLStrategic Sourcing Services, LLC51ec068b-e219-381a-384b-a208a306d5ba2025-12-10WarningsExact identifier
application applno (ANDA): 208369
application number: ANDA208369
Mucus DGUAIFENESIN 600 MG AND PSEUDOEPHEDRINE HCL 60 MGCVS Health Corp284bbf6a-8b34-09b6-3115-553a9ec831222025-12-10WarningsExact identifier
application applno (ANDA): 208369
application number: ANDA208369
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLWalgreens Company2619b68b-835a-c7f2-ecbc-39944d5ba8a52025-12-10WarningsExact identifier
application applno (ANDA): 208369
application number: ANDA208369
Guaifenesin and Pseudoephedrine HCLGUAIFENESIN AND PSEUDOEPHEDRINE HCLDr. Reddys Laboratories Limited845a2dcc-9069-3141-ae13-f2063f36d1302025-10-24WarningsExact identifier
application applno (ANDA): 208369
application number: ANDA208369
ndc (product): 55111-798
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLWal-mart Stores, Inc.f3933531-aa4d-cb67-1895-f2f14175f1d22025-10-10WarningsExact identifier
application applno (ANDA): 208369
application number: ANDA208369

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244675guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN845a2dcc-9069-3141-ae13-f2063f36d1309
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN845a2dcc-9069-3141-ae13-f2063f36d1309
124467512 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD845a2dcc-9069-3141-ae13-f2063f36d1309
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD845a2dcc-9069-3141-ae13-f2063f36d1309
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY845a2dcc-9069-3141-ae13-f2063f36d1309
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN284bbf6a-8b34-09b6-3115-553a9ec831227
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD284bbf6a-8b34-09b6-3115-553a9ec831227
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY284bbf6a-8b34-09b6-3115-553a9ec831227
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN9fb0c938-d24b-2371-95db-6c82d9511d724
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD9fb0c938-d24b-2371-95db-6c82d9511d724
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY9fb0c938-d24b-2371-95db-6c82d9511d724
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSNa438d709-61e3-ef35-a85c-4b92c3cff4283
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCDa438d709-61e3-ef35-a85c-4b92c3cff4283
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSYa438d709-61e3-ef35-a85c-4b92c3cff4283
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN51ec068b-e219-381a-384b-a208a306d5ba2
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD51ec068b-e219-381a-384b-a208a306d5ba2
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY51ec068b-e219-381a-384b-a208a306d5ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-798-09551110798091 BLISTER PACK in 1 CARTON (55111-798-09) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2017-12-290000-00-00NoNoCurrent
55111-798-18551110798182 BLISTER PACK in 1 CARTON (55111-798-18) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-12-290000-00-00NoNoCurrent
55111-798-35551110798351 BLISTER PACK in 1 CARTON (55111-798-35) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2020-01-230000-00-00NoNoCurrent
55111-798-36551110798364 BLISTER PACK in 1 CARTON (55111-798-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2017-12-290000-00-00NoNoCurrent
55111-798-41551110798412 BLISTER PACK in 1 CARTON (55111-798-41) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2020-03-110000-00-00NoNoCurrent
55111-798-77551110798776 BLISTER PACK in 1 CARTON (55111-798-77) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack29-DEC-17Current