FDA.reportPublic FDA data

good sense mucus er

Product NDC
0113-2023
11-digit product format
001132023
Labeler code
0113
Product ID
0113-2023_ce0344da-df70-4ceb-a64b-c71bb17d8b37
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA078912
Marketing category
ANDA
Marketing start
2020-07-04
Substance
GUAIFENESIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078912-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23
A078912-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05

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 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2384e616aacf4f…
2026-09-14 22:38:342026-08A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0584e616aacf4f…
2026-08-18 06:07:402026-07A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23bb7c543d1eb4…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
good sense mucus er
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
636522Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
def40c3f-29de-4efc-b1d3-4cb89183aaecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-2023-58good sense mucus er40 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL403
0113-2023-58good sense mucus er1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL13
0113-2023-60good sense mucus er1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL13
0113-2023-60good sense mucus er20 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-2023-58EA - Each0113-2023da17e939-5569-4a7c-85e5-13ec7435944512025-09-12
0113-2023-60EA - Each0113-2023db504b76-520e-44b1-8ece-c0a9aee4c2be12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-2023GOOD SENSE MUCUS ER (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 4 package rows20250302_def40c3f-29de-4efc-b1d3-4cb89183aaec.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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Mucus ERGUAIFENESINTopco Associates LLCb787eac7-8f87-49a2-899b-5f524eb7b1fc2025-05-29WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
Guaifenesin Extended-ReleaseGUAIFENESINPrecision Dose Inc.608b00c5-a2c7-4514-9b46-02954d6675d62025-05-27WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
Leader Mucus ReliefGUAIFENESINCardinal Health 110, LLC. dba Leader34981e01-f405-4feb-807b-3a8c02faca962025-03-09WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
Topcare mucus erGUAIFENESINTopco Associates LLCe3c900ad-21b1-4cd0-8c48-f54f115df4032024-12-12WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
DG Health Mucus ERGUAIFENESINDolgencorp, LLCbf99fa83-c3be-4052-b5b6-ad91997cb0342023-04-06WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
mucusGUAIFENESINCVS Pharmacyd6f1889e-8228-4c8c-a0e9-6c2afdc07e992023-01-25WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
basic care mucus erGUAIFENESINAmazon.com Services LLC14213a15-5842-456f-a5ab-654268c58f782022-04-11WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN608b00c5-a2c7-4514-9b46-02954d6675d63
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNdef40c3f-29de-4efc-b1d3-4cb89183aaec3
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD608b00c5-a2c7-4514-9b46-02954d6675d63
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDdef40c3f-29de-4efc-b1d3-4cb89183aaec3
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY608b00c5-a2c7-4514-9b46-02954d6675d63
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYdef40c3f-29de-4efc-b1d3-4cb89183aaec3
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN4fb57f87-f761-b52e-e063-6294a90ae4ee1
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD4fb57f87-f761-b52e-e063-6294a90ae4ee1
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY4fb57f87-f761-b52e-e063-6294a90ae4ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-2023-58001132023581 BOTTLE in 1 CARTON (0113-2023-58) / 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2023-07-19NoNoCurrent
0113-2023-60001132023601 BOTTLE in 1 CARTON (0113-2023-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-07-040000-00-00NoNoCurrent