FDA.reportPublic FDA data

Guaifenesin D

Product NDC
51316-993
11-digit product format
513160993
Labeler code
51316
Product ID
51316-993_85bd100e-7bbc-4ab0-9f19-e119a28f16d3
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
ANDA212542
Marketing category
ANDA
Marketing start
2021-05-06
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

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin D
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
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
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
4dee850b-b170-4ef9-ae02-3db9bfa05abeAvailable 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
51316-993-18Guaifenesin D1 in 1 CARTONTABLET, EXTENDED RELEASE14
51316-993-18Guaifenesin D18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE184
51316-993-36Guaifenesin D2 in 1 CARTONTABLET, EXTENDED RELEASE24
51316-993-36Guaifenesin D18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51316-993-18EA - Each51316-993a8622a64-5487-4a4e-a568-7fbe2f061eb912022-06-06
51316-993-36EA - Each51316-993c205bd28-8d5b-4f47-9881-41b56d6a39ad12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-993GUAIFENESIN D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CVS PHARMACY, INC.]4Current NDC, Legacy NDC, 4 package rows20220615_4dee850b-b170-4ef9-ae02-3db9bfa05abe.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
ndc (product): 51316-993
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN4dee850b-b170-4ef9-ae02-3db9bfa05abe4
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD4dee850b-b170-4ef9-ae02-3db9bfa05abe4
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY4dee850b-b170-4ef9-ae02-3db9bfa05abe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-993-18513160993181 BLISTER PACK in 1 CARTON (51316-993-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-05-060000-00-00NoNoCurrent
51316-993-36513160993362 BLISTER PACK in 1 CARTON (51316-993-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2021-05-060000-00-00NoNoCurrent